CLINICAL TRIAL UPDATE
DRY AMD
▪ Study: Age-Related Eye Disease Study II (AREDS II)
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: Investigate the effects of oral supplements of lutein/zeaxanthin and omega-3 fatty acids for the treatment of
AMD. A secondary randomization will
further refine the AREDS-type supplement
by testing lower dose of zinc and
eliminating beta-carotene
Design: Phase 3, randomized, prospective,
multicenter trial
Number of Patients: 4000
Number of Clinical Centers: 80 plus
Inclusion Criteria: Age 55 years to
80 years; bilateral large drusen (>125 μm)
or advanced AMD (neovascular AMD or
geographic atrophy involving the center
of fovea) in 1 eye only and presence of
large drusen in the fellow eye
Exclusion Criteria: Choroidal neovascularization
associated with other ocular
diseases such as pathologic myopia, ocular
histoplasmosis or posterior uveitis,
other confounding ocular disease or surgical
procedures (except for cataract
surgery or YAG laser)
Information: http://www.nei.nih.gov/
neitrials/viewStudyWeb.aspx?id=120
▪ Study: OT-551
Sponsor: Othera
Status: Enrolling patients
Purpose: To investigate whether the topically
applied antioxidant OT-551 can help
slow progression of atrophic “dry” AMD
Study Design: Randomized, doublemasked,
dose-ranging, multi-center, efficacy
and safety study
Number of Patients: 200
Inclusion Criteria: 55 or more years of
age; clinical diagnosis of geographic atrophy
in one or both eyes; area of the geographic
atrophy does not exceed 7 MPS
disc areas; best corrected visual acuity
score of 20/63 (Snellen equivalent) or
better; geographic atrophy is not secondary
to conditions other than AMD;
no choroidal neovascularization in either
eye; no confounding ocular conditions
or recent or planned surgery in the
study eye.
Information: Al Reaves, MD,
reaves@othera.com
▪ Study: Measuring Reading
Rehabilitation Outcomes
Sponsor: Department of Veteran Affairs
Status: Enrolling patients
Purpose: To measure the effectiveness
of a newly-designed oculomotor training
program for patients with AMD
Design: Educational, counseling, training,
nonrandomized, double-blind, active control,
crossover assignment, efficacy study
Number of Patients: 90
Inclusion Criteria: Established preferred
retinal locus; visual acuity of less than or
equal to 20/70 and greater than or equal
to 20/400 (in the better eye)
Exclusion Criteria: Major ophthalmologic
and neurologic disease; choroidal
neovascularization (“wet” AMD); moderate
to severe media opacities; and cognitive
impairment
Information: (312) 996-1466
▪ Study: Safety Study in Retinal
Transplantation for Dry AMD
Sponsors: Ocular Transplantation,
National Neurovision Research Institute
Status: Enrolling patients
Purpose: To show that retinal transplantation
can help to prevent blindness and to
restore eyesight in patients with dry AMD
Design: Treatment, nonrandomized,
open label, active control, factorial
assignment, safety/efficacy study
Number of Patients: 10
Inclusion Criteria: Decreased entral
visual acuity of 20/200 or worse in 1 eye
by ETDRS vision testing for a duration of
at least 1 year in the operated eye; vision
in the nonoperated eye must be better
than the operated eye; vision in the
operated eye cannot be better than
20/200; >55 years of age; patient has
undergone microperimetry and
Goldmann visual field testing
Exclusion Criteria: Medical problems
that are contraindicatory for short-term
anesthesia; pregnancy; features of any
condition other than AMD in the study
eye (such as pathologic myopia or presumed
ocular histoplasmosis) associated
with choroidal neovascularization; history
of choroidal neovascularization in
the study eye; prior photodynamic therapy
or Macugen therapy for choroidal
neovascularization; history of uveitis,
Coat’s disease, diabetic retinopathy,
glaucoma, or a cataract that prevents
visualization of the posterior pole
Information: (502) 636-2823
▪ Study: Study of Fenretinide in the
Treatment of Geographic Atrophy
Associated With Dry AMD
Sponsor: Sirion
Status: Currently enrolling
Purpose: To determine the efficacy of
fenretinide in the treatment of geographic
atrophy in subjects with the dry
form of AMD
Design: Multicenter, randomized, double-
masked, placebo-controlled, dose
comparison
Number of Patients: 225
Inclusion Criteria: Age from 50 to 89
years old; must have geographic atrophy
from AMD in one or both eyes
Exclusion Criteria: Geographic atrophy
due to any disease other than AMD
Contact: (813) 957-3449
▪ Study: RHEO-AMD
Sponsor: Occulogix
Status: Enrolling patients
Purpose: To evaluate Rheopheresis
treatment for dry AMD
Design: Multi-center, prospective, randomized,
double-masked study comparing
safety and efficacy
Number of Patients: 325
Inclusion Criteria: Subjects 50 – 85 yrs
and 50 – 100 kg; baseline study eye
ETDRS BCVA 20/40 – 20/100 (Snellen
equivalent); and, diagnosis of dry AMD
in Study Eye with ≥3 soft, semi-soft, or
confluent drusen ≥125 μm within 3,000
μm of foveal center (total equivalent
drusen surface area ≥31,000 μm2)
Exclusion Criteria: Previous or active
Choroidal Neovascularization (CNV);
Geographic Atrophy (GA) within 500 μm
of foveal center; GA ≥250 μm in diameter;
serous (non-drusenoid) pigment
epithelium detachment; nongeographic
hypopigmentation within 500 μm of
foveal center; or, significant opacities
causing vision decrease or limiting view
of fundus
Information: http://www.occulogix.com/
▪ Study: A Study of an Encapsulated
Cell Technology (ECT) Implant
for Patients With Atrophic
Macular Degeneration
Sponsor: Neurotech Pharmaceuticals
Status: Enrolling patients
Purpose: To look at the safety and effectiveness
of CNTF implants on vision in
participants with atrophic macular
degeneration.
Study Design: Treatment, Randomized,
Double-Blind, Dose Comparison,
Parallel Assignment, Safety/Efficacy
WET AMD
▪ Study: Clinical Trial to Explore the
Safety and Efficacy of
Injections of Macugen When
Given Every 6 Weeks in
Subjects With AMD
Sponsor: (OSI) Eyetech/Pfizer
Status: Enrolling patients
Purpose: To explore the safety and efficacy
of Macugen given as maintenance
therapy in patients who have had initial
success with another AMD treatment
Design: Treatment, non-randomized,
open-label, uncontrolled, single group
assignment
Number of Patients: 1000
Inclusion Criteria: Patients must have 1,
but not more than 3, prior treatments
for neovascular AMD
Information: (866) 622-8436
▪ Study: Safety and Efficacy of
Repeated Intravitreal
Administration of VEGF Trap
in Patients with Wet AMD
Sponsor: Regeneron Pharmaceuticals
Status: Enrolling patients
Purpose: To assess the ocular and
systemic safety and tolerability of
repeated intravitreal doses of VEGF
Trap in patients with subfoveal CNV
due to AMD
Design: Phase 2, randomized, doubleblind,
dose comparison, parallel assignment,
safety/efficacy
Number of Patients: 150
Inclusion Criteria: Age >50 years; subfoveal
CNV secondary to AMD; central
retinal (including lesion) thickness
≥300 μm as measured by OCT; ETDRS
BCVA of 73-34 letters
Exclusion Criteria: History of any vitreous
hemorrhage within 4 weeks
prior to day 1; aphakia; significant subfoveal
atrophy or scarring; prior treatment
with the following in the study
eye: subfoveal thermal laser therapy,
submacular surgery, or other surgical
intervention for the treatment of
AMD; extrafoveal laser coagulation
treatment within 12 weeks prior to
day 1; PDT within 12 weeks prior to
visit 2 (day 1); pegaptanib sodium
within 8 weeks of visit 2 (day 1); juxtascleral
steroids or anecortave acetate within
24 weeks (6 months) prior to visit 2
(day 1); intravitreal administration of triamcinolone
acetonide or other steroids
within 24 weeks prior to visit 2 (day 1)
unless no visible residue of drug substance
can be seen in the vitreous cavity
using indirect ophthalmoscopy; prior systemic
or intravitreal treatment with
VEGF Trap, ranibizumab, or bevacizumab
Information: Regeneron,
VEGF.Trap@regeneron.com
▪ Study: Imatinib Mesylate Combined
With Intravitreal Ranibizumab
in the Treatment of Choroidal
Neovascularization Secondary
to AMD
Sponsor: Vitreous Retinal Macula
Consultants of New York; Genentech
Status: Enrolling patients
Purpose: To determine if Lucentis combined
with imatinib mesylate will help
treatment in patients with newly diagnosed
choroidal neovascularization
Design: Treatment, nonrandomized,
open-label, active control, parallel
assignment, safety/efficacy study
Number of Patients: 15
Inclusion Criteria: BCVA letter score in
the study eye between 73-24 (approximately
20/40 to 20/320) using an ETDRS
chart; CNV lesion of any type in the
study eye; evidence that CNV extends
under the geometric center of the foveal
avascular zone area of the CNV must
occupy at least 50% of the total lesion;
lesion must be ≤4000 μm in greatest linear
dimension (GLD)
Exclusion Criteria: History of prior
PDT, external-beam radiation, subfoveal
focal laser photocoagulation, submacular
surgery, or transpupillary thermotherapy
in the study eye; atrophy
under the center of the fovea; angioid
streaks, presumed ocular histoplasmosis
syndrome, myopia (>6 D), or CNV
secondary to other causes than AMD;
receiving or require chronic concomitant
therapy with systemic (>5 mg) or
ocular corticosteroids.
Contact: (212) 452-6902
▪ Study: Study to Determine
Safety/Efficacy of Lucentis
for Treatment of Retinal
Angiomatous Proliferation
Secondary to AMD
Sponsor: The National Retina Institute/
Genentech
Status: Enrolling patients
Purpose: To determine the safety and
efficacy of ranibizumab for the treatment
of retinal angiomatous proliferation
secondary to AMD
Number of Patients: 20
Inclusion Criteria: Age >50 years; definite
characteristic signs of age related
macular degeneration (AMD) including
drusen; presence of retinal angiomatous
proliferation as determined by clinical
signs (intra retinal hemorrhage, retinal
edema, cystic retinal edema) and angiography
(occult leakage on fluorescein
angiography, hot spot on static ICG, visible
RAP lesion of high speed ICG)
Exclusion Criteria: Prior treatment with
verteporfin, external-beam radiation therapy,
or transpupillary thermotherapy in the
study eye; treatment with verteporfin in
the non-study eye less than 7 days preceding
Day 0; previous participation in a clinical
trial (for either eye) involving anti
angiogenic drugs (pegaptanib, ranibizumab,
anecortave acetate, protein kinase C
inhibitors, etc.); previous subfoveal focal
laser photocoagulation involving the foveal
center in the study eye; laser photocoagulation
(juxtafoveal or extrafoveal) in the
study eye within 1 month preceding Day 0;
history of vitrectomy, submacular surgery,
or other surgical intervention for AMD in
the study eye; previous participation in any
studies of investigational drugs within
1 month preceding Day 0 (excluding vitamins
and minerals)
Contact: (301) 986-8747
▪ Study: Ranibizumab in Hemorrhagic
Choroidal Neovascularization Trial
Sponsor: Johns Hopkins University/Genentech
Status: Enrolling patients
Purpose: To look at the effects of
ranibizumab on a condition called “predominantly
hemorrhagic subfoveal
choroidal neovascularization (CNV)” due
to wet AMD
Number of Patients: 10
Inclusion Criteria: Age >50 years old;
must have media clear enough to permit
fundus photography, fluorescein angiography,
and optical coherence tomography
Exclusion Criteria: Known hypersensitivity
to humanized monoclonal antibodies;
history (within past 6 months) or evidence
of severe cardiac disease (apparent
in electrocardiogram abnormalities,
clinical history of unstable angina, acute
coronary syndrome, myocardial infarction,
revascularization procedure within
6 months prior to baseline, atrial or ventricular
tachyarrhythmias requiring ongoing
treatment); history of stroke within
6 months of study entry; current acute
ocular or periocular infection; any major
surgical procedure within 1 month of
study entry; known serious allergies to
fluorescein dye
Contact: (443) 257-9692
▪ Study: LUV: Lucentis Utilizing
Visudyne Combination Therapy
in the Treatment of Age-
Related Macular Degeneration
Sponsor: Novartis/Greater Houston
Retinal Research
Status: Currently enrolling
Purpose: To determine whether the combination
of ranibizumab and PDT is an
effective and safe treatment for AMD.
Design: Treatment, Randomized, Open
Label, Dose Comparison, Parallel
Assignment, Efficacy Study
Number of Patients: 30
Inclusion Criteria: Age >55 years; subfoveal
neovascular membrane confirmed
by fluorescein angiography and
or ICG; visual acuity not better than
20/32 and not worse than 20/320 by
ETDRS refraction
Exclusion Criteria: Previous vitrectomy;
intracapsular cataract extraction; previous
treatment with ranibizumab, bevacizumab,
triamcinolone, or PDT; history
of retinal detachment; significant cardiovascular
disease or cancer that would
prevent follow-up visits or completion of
the 12 month study; prior enrollment in
any study for AMD
Information:
http://www.houstonretina.com/
▪ Study: A Study Using Intravitreal
Injections of a Small Interfering
RNA in Patients With Age-
Related Macular Degeneration
Sponsor: Allergan
Status: Currently enrolling
Purpose: To evaluate multiple doses of
AGN211745 (previously known as Sirna-
027) in treatment of subfoveal choroidal
neovascularization associated with agerelated
macular degeneration
Design: Treatment, Randomized, Single
Blind, Active Control, Parallel
Assignment, Safety/Efficacy Study
Number of Patients: 135
Inclusion Criteria: 50 years or older
with “wet” AMD as determined by an
ophthalmologist; decrease in visual
acuity (20/40 to 20/400) in at least
one eye
Exclusion Criteria: Uncontrolled systemic
disease; history of heart attack or
stroke within one year of study entry;
symptomatic coronary artery disease;
cataracts that interfere with vision
Information: clinicaltrials@allergan.com
▪ Study: Efficacy/Safety of Verteporfin
Photodynamic Therapy and
Ranibizumab Compared With
Ranibizumab in Patients With
Subfoveal Choroidal
Neovascularization
Sponsor: Novartis
Status: Currently enrolling
Purpose: To evaluate the effect of combination
therapy with verteporfin photodynamic
therapy and ranibizumab on
visual acuity and anatomic outcomes
compared to ranibizumab monotherapy
and the durability of response observed
in patients with choroidal neovascularization
secondary to age-related macular
degeneration.
Design: Treatment, Randomized, Double-
Blind, Active Control, Parallel
Assignment, Safety/Efficacy Study
Number of Patients: 318
Inclusion Criteria: Subjects of either gender
age 50 years or older; subfoveal
choroidal neovascularization (CNV) due to
age-related macular degeneration (AMD)
Exclusion Criteria: Choroidal neovascularization
due to causes other than
AMD; prior treatment for neovascular
AMD in the study eye
Information: Brandi Teske,
bteske@westcoastretina.com
▪ Study: A Phase I Trial of a Single
Intravitreal Injection of
REDD14NP to Patients With
CNV Secondary to Wet AMD
Sponsor: Quark Biotech, Inc.
Status: Enrolling patients
Purpose: To determine the safety and
pharmacokinetics of REDD14NP when
administered as a single intravitreal
injection.
Study Design: Treatment, Non-Randomized,
Open Label, Uncontrolled, Single
Group Assignment, Safety Study
Number of Patients: 42
Inclusion Criteria: Documented CNV
secondary to AMD; clear ocular media
and adequate pupil dilation; IOP ≤25 mm
Hg; retinal thickness >250 um by OCT;
BCVA not better than 20/200
Exclusion Criteria: Women of childbearing
potential; CNV due to causes other
than AMD; underlying disease or other
disease of the eye; therapy for AMD in
either eye in last 30 days; steroid therapy
for AMD in last six months; history
of intraocular surgery other than
cataract surgery or of retinal detachment
in the study eye
Information: (212) 452-6902
▪ Study Name: Study of Treatment
Effects of Combination
Therapy of Lucentis Plus
Reduced-Fluence PDT in
Patients With Wet AMD
Sponsor: Barnes Retina Institute
Status: Enrolling patients
Purpose: To determine the benefits, if
any, of combination therapy with Lucentis
plus reduced-fluence PDT with Visudyne
Study Design: Treatment, Randomized,
Open Label, Active Control, Single
Group Assignment, Safety/Efficacy
Study
Inclusion Criteria: Treatment-naïve
patients with active, subfoveal, exudative
AMD; visual acuity of 20/40-20/320 in
the study eye; subfoveal CNV must be
at least 50% of the total lesion size; total
area of lesion components other that
CNV must be less than 50% of the total
lesion size; lesion must be < 5400 μm in
greatest linear dimension (GLD); lesion
size < 10 DA
Exclusion Criteria: Previous treatment
for CNV with anti-VEGF agents, intraocular
steroids, and/or PDT with Visudyne; geo-
graphic atrophy or fibrosis in the study
eye; intraocular surgery within 6 weeks
of enrollment; subretinal hemorrhage >
50% of the total lesion; intraocular pressure
greater than 30 mm Hg on 2 pressure-
lowering medications; severe
disciform scarring; advanced glaucoma;
allergies to porfins or a known hypersensitivity
to any component of Visudyne;
porphyria, pregnancy, or lactation.
Information: bristudies@barnesretinainstitute.
com
▪ Study: TAPER: Second-line Therapy to
Treat AMD for Patients Not
Responding Well to Lucentis
Therapy by Itself
Sponsor: Vitreous Retina Macula
Consultants of New York/QLT Inc.
Status: Enrolling patients
Purpose: To demonstrate that Visudyne-
Lucentis-Dexamethasone triple therapy
will give similar efficacy and safety
results as Lucentis monotherapy
Study Design: Randomized, Masked,
Efficacy Study
Inclusion Criteria: Patients with subfoveal
CNV due to AMD who, after 2 to
6 previous treatments with Lucentis
monotherapy, continue to have exudative
activity associated with the CNV
lesion 4 to 8 weeks after the last treatment;
all lesion composition types with a
lesion greatest linear dimension (GLD)
≤5400 microns (approximately ≤9 disc
areas [DA]); BCVA score of 25 to 73 letters
(approximate Snellen equivalent of
20/40 to 20/320)
Exclusion Criteria: Subfoveal geographic
atrophy or subfoveal fibrosis in
the study eye; intraocular surgery within
3 months of enrollment
Information: (604) 742-1025
SCREENING
▪ Study: Evaluation and Treatment of
Patients with Retinal Disease
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To allow National Eye Institute
physicians to increase their knowledge of
retinal eye diseases and identify possible
new avenues of research in this area
Design: Natural history
Number of Patients: 500
Inclusion Criteria: Diagnosis of AMD
Exclusion Criteria: Inability to be followed
for 3 years
Contact: (800) 411-1222
▪ Study: Screening for Studies on
Retinovascular Diseases
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To help recruit patients for
National Eye Institute (NEI) studies of
the retina
Design: Natural history
Number of Patients: 1500
Inclusion and Exclusion Criteria:
Inclusion and exclusion criteria vary with
the particular protocol for which a
patient is being screened. In addition to
those diagnoses currently under study,
subjects with unknown conditions that
require the establishment of a diagnosis
may be eligible for inclusion in this
study. All studies of retinovascular diseases
require the subject to have minimum
age of 18 years in both men and
women
Contact: (800) 411-1222
▪ Study: Genetic Factors in AMD
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine whether certain
polymorphisms predispose people to
develop AMD
Design: Screening
Number of Patients: 400
Inclusion Criteria: (AMD patients) Age
≥50 years; diagnosis of advanced AMD
defined by geographic atrophy and/or
CNV with drusen of any size in at least
1 eye; (Control patients) Age >70 years;
absence of drusen or no more than
5 drusen <63 μm; absence of other diagnostic
criteria for AMD
Exclusion Criteria: Presence of retinal
disease involving the photoreceptors
and/or outer retinal layers other
than AMD loss such as high myopia,
retinal dystrophies, central serous
retinopathy, vein occlusion, diabetic
retinopathy and uveitis or similar outer
retinal diseases that have been present
prior to the age of 50; opacities
of the ocular media; limitations of
papillary dilation or other problems
sufficient to preclude adequate
stereo fundus photography (occluded
pupils due to synechia, cataracts,
vitreous haze, and opacities due to
ocular diseases)
Information: (800) 411-1222
▪ Study: Investigating Age-Related
Macular Degeneration
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine an Amish community
to investigate genetic factors in the
development of AMD
Design: Natural history
Number of Patients: 1000
Inclusion Criteria: All Amish individuals,
≥50 years
Information: (301) 496-6583
▪ Study: Ultrasonic Evaluation of Ocular
Tissues
Sponsor: Weill Medical College of
Cornell University/Riverside Research
Institute
Status: Currently enrolling
Purpose: To improve diagnosis and
treatment monitoring of ophthalmic disease
by improving diagnostic ultrasound
techniques
Design: Screening, Cross-Sectional,
Defined Population, Retrospective/
Prospective Study
Number of Patients: 150
Inclusion Criteria: Have one of the following
eye diseases: Glaucoma Ocular
Tumors Age-Related Macular
Degeneration
Information: (212) 746-6106
▪ Study: Screening for Studies on
Inherited Eye Diseases
Sponsor: NEI
Status: Currently enrolling
Purpose: To help recruit patients for
National Eye Institute (NEI) studies on
inherited eye diseases
Design: Natural History
Number of Patients: 800
Inclusion/Exclusion Criteria: Inclusion
and exclusion criteria vary with the particular
protocol for which a patient is
being screened. in addition to those
diagnoses currently under study, subjects
with unusual, interesting, or
unknown conditions that require the
establishment of a diagnosis, may be eligible
for inclusion in this study
Information: (800) 411-1222
RETINAL IMAGING STUDIES
▪ Study: Retinal Imaging in Patients
With Inherited Retinal
Degenerations
Sponsor: University of California-San
Francisco/University of California-
Berkeley
Status: Enrolling patients
Purpose: To determine whether the
structure and function of the human
retina can be studied with high resolution
in patients with inherited retinal
degenerations using the Adaptive Optics
Scanning Laser Ophthalmoscope
Design: Natural history, longitudinal,
defined population, prospective study
Number of Patients: 130
Inclusion Criteria: Subjects must have
pupils that dilate to at least 6 mm diameter
and must be willing to travel to UC
Berkeley
Exclusion Criteria: Cataract; irregular
corneal astigmatism (keratoconus); prior
refractive surgery
Information: Jacque L. Duncan, MD,
(415) 514-4241, duncanj@vision.ucsf.edu
▪ Study: Novel Diagnostics for Ocular
Structure
Sponsor: University of Pittsburgh/
National Institutes of Health
Status: Enrolling patients
Purpose: To evaluate novel technologies
for the assessment of ocular structure
and function, including the scanning
device called optical coherence tomography
(OCT).
Design: Natural history, longitudinal,
defined population, retrospective/
prospective Study
Number of Patients: 500
Inclusion Criteria: Diagnosis of macular
degeneration, diabetic retinopathy,
and/or glaucoma
Exclusion Criteria: Media opacity (lens,
vitreous, cornea); diagnosis of strabismus,
nystagmus, or a condition that
would prevent fixation
Information: Tammy J Capozzoli,
(412) 647-2375, capozzolitj@upmc.edu
▪ Study: Metabolic Mapping to Measure
Retinal Metabolism
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To test whether a new noninvasive
technique can quickly and precisely
measure retinal metabolism (the
amount of energy retinal cells use)
Design: Diagnostic, nonrandomized,
open-label, uncontrolled, single-group
assignment, efficacy study
Number of Patients: 30
Inclusion Criteria: Presence of a natural
lens in the study eye; age 60 years or older
Exclusion Criteria: Ocular disease
(other than AMD) that confounds
assessment of the retina including diabetic
retinopathy, central serous
choroidopathy, optic atrophy, retinal vein
occlusion, active uveitis, significant
explained or unexplained visual field
loss, or any other type of retinopathy or
retinal degeneration
Information: (800) 411-1222
▪ Study: AMD DOC Study (Age-Related
Macular Degeneration:
Detection of Onset of New
Choroidal Neovascularization)
Sponsor: Johns Hopkins University
Status: Enrolling patients
Purpose: To compare the ability of the
Preferential Hyperacuity Perimeter
(PHP) to that of the Amsler grid in
detecting neovascular AMD in eyes at
high risk for CNV development
Design: Screening, Longitudinal, Defined
Population, Prospective Study
Number of Patients: 180
Inclusion Criteria: Age ≥50; best corrected
visual acuity letter score = 65 or
greater (approximate Snellen equivalent
of 20/50 or better in the candidate
study eye); neovascular AMD in the fellow
eye and no CNV in the candidate
study eye (absence of CNV confirmed
by FA which will be graded in a masked
fashion by the AMD DOC Study
Reading Center); candidate study eye
must have evidence of at least 1 large
druse (≥125 μm) and focal hyperpigmentation
within 3600 μm of the fovea and
visible on color fundus photography;
must have media clear enough in the
candidate study eye to permit fundus
photography, fluorescein angiography,
and optical coherence tomography and
absence of any fluorescein allergies.
Exclusion Criteria: Known allergy to fluorescein
angiography or allergic reaction
during screening; advanced AMD with
CNV in both eyes confirmed on FA
graded by the AMD DOC Study Reading
Center; foveal geographic atrophy in the
study eye; significant media opacity that
precludes reasonable quality retinal
imaging including color fundus photographs,
fluorescein angiography, or
OCT in the candidate study eye to
assess the presence of CNV; evidence
of macular disease (eg, pattern dystrophy,
diabetic macular edema, vitreomacular
traction) other than AMD in the
study eye; previous surgical or laser
treatment to the macula of the study
eye; diabetic retinopathy
Information: (410) 955-3648
▪ Study: Novel Diagnostics With Optical
Coherence Tomography:
Retinal Imaging
Sponsor: University of Pittsburgh
Status: Currently enrolling
Purpose: To evaluate optical coherence
tomography (OCT) and FDA approved
device used to image diseases of the eye
Design: Screening, Longitudinal,
Convenience Sample, Retrospective/
Prospective Study
Number of Patients: 1500
Inclusion Criteria: Subjects with healthy
eyes, macular degeneration, glaucoma
and other various eye diseases. Also
must be able to fixate on target.
Exclusion Criteria: Fundus not visible or
opaque media
Information: (412) 647-2375
DIABETIC MACULAR EDEMA
▪ Study: Evaluation of Vitrectomy for
DME
Sponsor: Diabetic Retinopathy
Clinical Research Network
Number of sites: 29
Number of Patients: approximately 400
Status: Enrolling patients
Purpose: To provide information on the
following outcomes in eyes with DME that
undergo vitrectomy: visual acuity, retinal
thickening, resolution of traction (if present),
surgical complications; to identify
subgroups in which there appears to be a
benefit of vitrectomy and subgroups in
which vitrectomy does not appear to be
beneficial; to obtain data that can be
used to plan a randomized trial
Design: The study is designed as a
prospective cohort study. A cohort study
provides the opportunity to collect data
prospectively using a standardized pro-
tocol to assess the potential benefits
and risks of vitrectomy. The results can
be used to determine whether proceeding
with a randomized trial has merit and
what the design of the trial should be. If
a randomized trial is to be conducted,
the results plus the cohort study experience
can be used to help design the
RCT protocol
Inclusion/Exclusion Criteria: Age ≥18
years old, study eye with vitrectomy
being performed as treatment of DME,
study eye with best corrected visual acuity
20/800 or better (E-ETDRS visual
acuity score ≥3 letters)
Information: http://public.drcr.net/
studies/ProtocolD_vitrectomy/
ProtDInfo.html
▪ Study: An Observational Study of the
Development of DME
Following Scatter Laser
Photocoagulation
Sponsor: Diabetic Retinopathy
Clinical Research Network
Number of sites: 18
Number of Patients: approximately 150
Status: Enrolling patients
Purpose: To determine the incidence
and extent of macular edema following
scatter laser photocoagulation
surgery using OCT in eyes without
macular edema prior to scatter laser
photocoagulation, and to explore
whether the incidence and extent of
macular edema varies according to
the number of sittings included in the
treatment regimen
Design: Prospective, multicenter, nonrandomized
clinical trial
Inclusion/Exclusion Criteria: Age ≥18
years, study eye with (1) OCT center
point thickness ≥200 μm and (2) early
proliferative or severe nonproliferative
diabetic retinopathy for which
investigator intends to perform full
scatter photocoagulation in either
1 sitting or 4 sittings
Information: http://public.drcr.net/
studies/ProtocolF_prp/ProtFInfo.html
▪ Study: Subclinical DME Study
Sponsor: Diabetic Retinopathy
Clinical Research Network
Number of sites: 18
Number of Patients: Approximately
1000 patients will be enrolled in order
to follow 220 patients
Status: Recruiting
Purpose: To determine how often
study participants’ eyes with subclinical
DME (defined as no edema
involving the center of the fovea as
determined by biomicroscopy but with
center point thickness on OCT of at
least 200 μm but less than or equal to
299 μm) progress over a 2-year period
to edema on OCT of at least 300 μm
(which is almost always clinically apparent)
and increase at least 50 μm from
baseline or are treated for DME among
individuals with more than minimal
retinopathy (greater than level 20), and
to determine mean OCT retinal thickness
measurements and confidence
intervals in subjects with diabetes and
no or minimal nonproliferative diabetic
retinopathy (level 20 or less)
Design: Prospective, multicenter, observational
study. The study consists of a
baseline phase and follow-up phase
Inclusion/Exclusion Criteria: Age ≥18
years, study eye with best corrected
E-ETDRS acuity ≥74 letters (20/32 or
better)
Information: http://public.drcr.net/
studies/ProtocolG_subclinical/
ProtGInfo.html
▪ Study: FAME (Fluocinolone Acetonide
in Macular Edema)
Sponsor: Alimera Sciences & Controlled
Delivery Systems
Number of Sites: Approximately 100
Number of Patients: More than 900
Status: Phase 3 initiated
Purpose: To evaluate the safety and efficacy
of sustained-release fluocinolone
acetonide, at 2 doses, delivered via the
Medidur intraocular sustained delivery
system
Design: Double-masked, randomized,
multicenter, parallel group, controlled
study
Inclusion/Exclusion Criteria: Patients
diagnosed with DME, who have
previously had laser treatment
Information: www.alimerasciences.com
▪ Study: Reduction in the Occurrence of
Center-threatening DME
Sponsor: Eli Lilly and Company
Status: Enrolling patients
Purpose: Determine whether ruboxistaurin
can slow the progression of DME
Design: Randomization 1:1, ruboxistaurin/
placebo
Inclusion Criteria: Type 1 or type 2
diabetes; >18 years; nonclinically significant
DME; mild to moderate diabetic
retinopathy in the study eye or vitreous
hemorrhage in the study eye; relatively
good vision (20/30 or better)
Exclusion Criteria: Surgery or laser
treatment in the study eye; glaucoma
in the study eye; HbA1c >11%, or systolic
blood pressure <170 mm Hg Information: (877) 285-4559
▪ Study: Efficacy Study of Lucentis in
the Treatment of Diabetic
Macular Edema
Sponsor: Rocky Mountain Retina
Consultants/Genentech
Purpose: To evaluate the clinical efficacy
of intravitreal injections of ranibizumab
(Lucentis) in the treatment of DME as
compared to grid/focal laser
Design: Treatment, randomized, openlabel,
active control, parallel assignment,
efficacy study
Number of Patients: 60
Inclusion Criteria: Clinically significant
diabetic macular edema (CSME) or clinically
significant diabetic macular edema
with center involvement (CSME-CI) as
defined by the ETDRS Trial (ETDRS
Research Group 1987 and 1991); retinal
thickening within 500 mm of the center
of the fovea; hard exudates within
500 mm of the center of the fovea (if
associated with adjacent retinal thickening,
which may be outside of 500 μm
limit); area of macular edema greater
than 1 disc area but within 1 disc diameter
of the center of the macula; age >21 years;
visual acuity < 20/320 with definite retinal
thickening due to diabetic macular
edema based on clinical exam; retinal
thickness on OCT measuring 250 μm or
more in the central subfield or 350 μm of
more in any non-central subfield; media
clarity and pupillary dilatation, patient
cooperation, and adequate fundus photographs
and OCT will be obtainable; no
other ocular conditions that could cause
macular edema will be present Exclusion Criteria: IOP exceeds 25 mm
Hg; pregnancy or premenopausal women
not using birth control; current treatment
of a systemic infection; evidence of significant
uncontrolled concomitant diseases
such as cardiovascular disease, nervous
system, pulmonary, renal, hepatic,
endocrine, or gastrointestinal disorders;
history of recurrent significant infections
or bacterial infections
Information: (801) 264-4444
▪ Study: Safety and Tolerability of
MS-R001 in Patients With DME
Secondary to Diabetic
Retinopathy
Sponsor: MacuSight
Status: Currently enrolling
Purpose: To determine the safety and
tolerability of MS-R001 at escalating
doses in patients with diabetic macular
edema secondary to diabetic retinopathy
Study Design: Randomized, Open
Label, Dose Comparison, Single Group
Assignment, Safety Study
Number of Patients: 30
Inclusion Criteria: Diagnosis diabetes
mellitus; visual acuity of 20/40 to 20/200
in study eye
Exclusion Criteria: Any other ocular disease
that could compromise vision in the
study eye; intraocular surgery of the
study eye within 90 days prior to study
start; capsulotomy of the study eye
within 30 days prior to study start
Information: (602) 222-2221 or
(817) 749-0180
▪ Study: Intravitreal vs Sub-Tenon
Injections of Triamcinolone
Acetonide for Macular Edema
in Retinal Disorders
Sponsor: NEI
Status: Enrolling patients
Purpose: To evaluate the long-term
safety and potential efficacy of novel
intravitreal injections of a preservativefree
formulation of triamcinolone acetonide
(TAC-PF) at two dosage levels
(4 mg and 8 mg) compared to anterior
sub-tenon injections of TAC-PF at 20 mg
Design: Masked, randomized, interventional
phase 1 study
Number of Patients: 120
Inclusion Criteria: Retinal thickening
due to macular edema in the study eye;
retinal thickness greater than or equal to
250 microns in the central subfield on
OCT; BCVA equal to or worse than
20/40 in the study eye; sufficiently clear
ocular media to permit good quality retinal
photographs and angiography to
allow assessment of macular area
according to standard clinical practice
Exclusion Criteria: IOP greater than
25 mm Hg or history suggesting glaucoma
or glaucomatous visual field
defects as documented by Goldmann or
Humphrey perimetry taken within
6 months to qualification; allergy to fluorescein
dyes; blood pressure greater
than 180/110; use of medications known
to be toxic to the lens, retina, or optic
nerve; previous experimental therapies
for the present disease in the past
3 months; history of or current acute
ocular or periocular infection; major
intraocular surgical procedure within
1 month of enrollment; use of systemic
steroids in excess of an average 20 mg
daily dose for the past 3 months; history
of untoward complications from corticosteroid
therapy, including elevated
intraocular pressure in response to topical
or periocular corticosteroids
Information: (800) 411-1222
▪ Study: Study of the Safety and
Efficacy of a New Treatment
for Diabetic Macular Edema
Sponsor: Allergan
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy
of an intravitreal implant of dexamethasone
for the treatment of diabetic
macular edema
Study Design: Treatment, Randomized,
Double-Blind, Dose Comparison, Parallel
Assignment, Safety/Efficacy Study
Number of Patients: 860
Inclusion Criteria: Diagnosis of DME;
decrease in visual acuity in at least one
eye as a result of macular edema (20/50
or worse); visual acuity in other eye no
worse than 20/200
Exclusion Criteria: Known anticipated
need for ocular surgery within next
12 months; history of glaucoma or current
high eye pressure requiring more
than 1 medication; uncontrolled systemic
disease; known steroid-responder; use
of systemic steroids or warfarin/heparin
Information: clinicaltrials@allergan.com
▪ Study: READ-2 (Ranibizumab for
Edema of the mAcula in
Diabetes)
Sponsor: Johns Hopkins/Juvenile
Diabetes Research Foundation/
Genentech
Status: Enrolling patients
Purpose: To compare ranibizumab to
laser therapy in the treatment of DME
Study Design: Treatment, Randomized,
Open Label, Uncontrolled, Parallel
Assignment, Safety/Efficacy Study
Number of Patients: 125
Inclusion Criteria: Diagnosis of diabetes
mellitus; retinal thickening secondary to
diabetes mellitus (diabetic macular
edema) involving the center of the fovea;
diagnosis must be confirmed by OCT
images; foveal thickness of greater than
250, as assessed by OCT; BCVA score in
the study eye of 20/40 to 20/320 inclusive
(Snellen equivalents using the
ETDRS protocol at a distance of 4 m)
Exclusion Criteria: Panretinal photocoagulation
or macular photocoagulation
within 3 months of study entry in the
study eye; use of intraocular or periocular
injection of steroids in the study eye
within 3 months of study entry; previous
participation in a study and receipt of
anti-angiogenic drugs (pegaptanib
sodium, ranibizumab, anecortave
acetate, protein kinase C inhibitor, etc.)
within 2 months of study entry; proliferative
diabetic retinopathy in the study
eye, with the exceptions of inactive,
fibrotic proliferative diabetic retinopathy
that has regressed following pan-retinal
laser photocoagulation or tufts of NVE
less than one disc area with no vitreous
hemorrhage; vitreomacular traction or
epiretinal membrane in the study eye
evident biomicroscopically or by OCT;
structural damage to the center of the
macula in the study eye likely to preclude
improvement in visual acuity following
the resolution of macular edema,
including atrophy of the retinal pigment
epithelium, subretinal fibrosis, laser
scar(s), macular ischemia, or organized
hard exudate plaque; ocular disorders in
the study eye that may confound interpretation
of study results, including retinal
vascular occlusion, retinal
detachment, macular hole, or choroidal
neovascularization of any cause; concurrent
disease in the study eye that could
compromise visual acuity or require
medical or surgical intervention during
the first 6-month study period; eyes that
are likely to need cataract surgery and
intraocular lens implantation within the
first 6 months of the study; cataract
surgery in the study eye within 3 months
of study entry; Yttrium-Aluminum-
Garnet (YAG) laser capsulotomy within
2 months of study entry; or any other
intraocular surgery within 3 months preceding
Day 0; history of vitreoretinal
surgery in the study eye within 3 months
of study entry; uncontrolled glaucoma or
diabetes mellitus; premenopausal
women not using adequate contraception
or pregnant women; history of gastrointestinal
bleeding within 2 months of
study enrollment, of major gastrointestinal,
cardiothoracic, gynecological, genitourinary,
or orthopedic surgeries within
2 months of study enrollment, or of
cerebral vascular accident, myocardial
infarction, transient ischemic attacks
within 6 months of study enrollment;
anyone on renal dialysis
Information: (410) 502-1713
▪ Study: The Course of Response to
Focal Photocoagulation for
DME
Sponsor: NEI
Status: Currently enrolling
Purpose: To determine the course of
changes in OCT measured macular
thickness and visual acuity following a
single session of focal photocoagulation
for center-involved DME
Design: Longitudinal, Defined
Population, Prospective Study
Number of Patients: 110
Inclusion Criteria: Age ≥18 years; diagnosis
of diabetes mellitus (type 1 or type 2;
best corrected E-ETDRS visual acuity letter
score ≥24 (i.e., 20/320 or better)
within 8 days of enrollment; definite retinal
thickening due to diabetic macular
edema involving the center of the macula
Exclusion Criteria: Significant renal disease;
blood pressure > 180/110 (systolic
above 180 OR diastolic above 110);
edema caused by other than DME; VA
loss that would not improve with treatment
of macular edema; substantial
cataract
Information: (866) 372-7601
▪ Study: Laser-Ranibizumab-
Triamcinolone for Diabetic
Macular Edema (LRT for DME)
Sponsor: NEI/Genentech/Allergan
Status: Currently enrolling
Purpose: To find out which is a better
treatment for DME: laser alone, laser
combined with an intravitreal injection of
triamcinolone, laser combined with an
intravitreal injection of ranibizumab, or
intravitreal injection of ranibizumab alone.
Study Design: Treatment, Randomized,
Single Blind, Active Control, Parallel
Assignment, Efficacy Study
Number of Patients: 701
Inclusion Criteria: Age ≥18 years; diagnosis
of diabetes mellitus (type 1 or type 2)
Exclusion Criteria: Significant renal disease;
participation in an investigational
trial within 30 days of randomization that
involved treatment with any drug that
has not received regulatory approval at
the time of study entry; known allergy to
any component of the study drug; blood
pressure > 180/110 (systolic above 180 OR
diastolic above 110); myocardial infarction,
other cardiac event requiring hospitalization,
stroke, transient ischemic attack, or
treatment for acute congestive heart failure
within 4 months prior to randomization;
systemic anti-VEGF or pro-VEGF
treatment within 4 months prior to randomization;
pregnancy
Information: (866) 372-7601 x218
RETINAL VEIN OCCLUSION
▪ Study: The Standard Care vs
COrticosteroid for REtinal Vein
Occlusion (SCORE) Study
Sponsor: National Eye Institute/National
Institutes of Health/Department of
Health and Human Services
Status: Enrollment began in October
2004
Purpose: To compare the effectiveness
and safety of standard care to intravitreal
injection(s) of triamcinolone for
treating macular edema (swelling of the
central part of the retina) associated
with CRVO and BRVO
Design: Multicenter, randomized, phase
3 trial. Eligible patients within each of
these 2 disease entities are randomized
in a 1:1:1 ratio to 1 of 3 groups: standard
care, intravitreal injection(s) of 4 mg of
triamcinolone acetonide, or intravitreal
injection(s) of 1 mg of triamcinolone
acetonide. Enrolled patients are followed
for 3 years. The preparation of
triamcinolone acetonide used in the
study is specially made for injection
into the eye and does not contain any
preservatives
Inclusion/Exclusion Criteria: Participants
with macular edema associated with
CRVO and BRVO who are 18 years of age
or older and are willing to provide consent.
Detailed inclusion/exclusion criteria
are available on the SCORE Web site at
http://spitfire.emmes.com/study/score
Number of Patients: 1260; 630 with
CRVO and 630 with BRVO
Site(s): 27
Information: (301) 251-1161
▪ Study: RAVE: Rubeosis Anti-VEGF
Trial for Ischemic Central
Retinal Vein Occlusion
Sponsor: Greater Houston Retina
Research
Status: Enrolling patients
Purpose: To see if total VEGF blockade
will prevent neovascular glaucoma and
eliminate the need for panretinal photocoagulation
in patients with ischemic
central retinal vein occlusion
Study Design: Treatment, Randomized,
Open Label, Active Control, Parallel
Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Ischemic CRVO
within 3 months of enrollment as per the
following inclusion criteria; VA 20/200 or
worse; RAPD 0.9 LU or worse; loss of
1-2e isopter on Goldmann Visual field;
ERG demonstrating B-wave amplitude
less than 60% of A wave
Exclusion Criteria: Angle neovascularization
greater than 3 clock hours
with IOP over 30 (Neovascular glaucoma);
any previous retinal laser photocoagulation
to the study eye, any
previous intravitreal injection in study
eye (triamcinolone or other), or any
previous vitrectomy in study eye (posterior
or anterior associated with vitreous
loss in cataract surgery);
intracapsular cataract extraction (posterior
capsule needs to be present);
previous history of retinal detachment
in study eye; any previous radiation
treatments to head/neck; significant
cardiovascular disease or cancer that
would prevent follow-up visits or completion
of the 12-month study or significant
diabetic retinopathy in the
fellow eye (diabetic macular edema,
proliferative diabetic retinopathy, or
high-risk non-proliferative diabetic
retinopathy); pregnancy
Information: (713) 524-3434
▪ Study: Lucentis for Macular Edema
Secondary to Vein Occlusions
Sponsor: Johns Hopkins/Genentech
Status: Enrolling patients
Purpose: To assess the bioactivity of
3 intravitreous injections 0.5 mg or 0.3 mg
of ranibizumab in patients with macular
edema due to central and branch retinal
vein occlusions and correlate activity with
peak and trough aqueous levels
Study Design: Treatment, Randomized,
Open Label, Dose Comparison,
Parallel Assignment, Safety/Efficacy
Study
Number of Patients: 40
Inclusion Criteria: Diagnosis of macular
edema due to central or branch retinal
vein occlusion; BCVA in the study eye of
20/40 to 20/320 inclusive (Snellen equivalents
using the ETDRS protocol at a
distance of 4 meters)
Exclusion Criteria: Scatter laser photocoagulation
or macular photocoagulation
within 3 months of study entry in the
study eye; use of intraocular or periocular
injection of steroids in the study eye
(e.g., triamcinolone) within 3 months of
study entry; previous participation in a
study and receipt of anti-angiogenic
drugs (pegaptanib sodium [EYE001],
ranibizumab, anecortave acetate, protein
kinase C inhibitor, etc.) within
3 months of study entry; vitreomacular
traction or epiretinal membrane in the
study eye evident biomicroscopically or
by OCT; ocular inflammation (including
1+ or above in the amount of cells) in the
study eye; history of idiopathic or
autoimmune uveitis in either eye; structural
damage to the center of the macula
in the study eye likely to preclude
improvement in visual acuity following
the resolution of macular edema, including
atrophy of the retinal pigment
epithelium, subretinal fibrosis, laser
scar(s), macular ischemia, or organized
hard exudate plaque; ocular disorders in
the study eye that may confound interpretation
of study results, including diabetic
retinopathy, retinal detachment,
macular hole, or choroidal neovascularization
of any cause (e.g., AMD, ocular
histoplasmosis, or pathologic myopia);
concurrent disease in the study eye that
could compromise visual acuity or
require medical or surgical intervention
during the study period; ontraocular
surgery in the study eye within 3 months
of study entry; uncontrolled glaucoma;
infectious blepharitis, keratitis, scleritis,
or conjunctivitis (in either eye) or current
treatment for serious systemic
infection; blood pressure exceeding
160/95 (sitting) during the screening
period; renal failure requiring dialysis or
renal transplant; premenopausal women
not using adequate contraception; previous
participation in other studies of
investigational drugs (excluding vitamins
and minerals) within 3 months
Information: (410) 955-5106
▪ Study: Lucentis for Central Retinal
Vein Occlusion (CRVO)
Sponsor: California Retina Consultants/
Genentech
Status: Enrolling patients
Purpose: To determine whether
ranibizumab will be effective in reducing
if not eliminating the macular edema
associated with the disease, central retinal
vein occlusion
Study Design: Treatment, Randomized,
Open Label, Dose Comparison,
Crossover Assignment, Safety/Efficacy
Study
Number of Patients: Contact company
Inclusion Criteria: Age >18 years; clinical
evidence of perfused central retinal vein
occlusion. A central retinal vein occlusion
(CRVO) is defined as an eye that
has retinal hemorrhages and a dilated
retinal venous system in all 4 quadrants;
central macular edema present on clinical
examination and OCT testing with a
central point thickness >250 μm; visual
acuity score greater than or equal to
19 letters (20/400) and less than or equal
to 73 letters (20/40) by the ETDRS visual
acuity protocol; media clarity, pupillary
dilation and patient cooperation sufficient
to allow OCT testing and retinal
photography
Exclusion Criteria: Pregnant women or
premenopausal women not using adequate
contraception; uncontrolled
hypertension; significant diabetic
retinopathy (greater than moderate
NPDR) or macular edema associated
with diabetic retinopathy; evidence of
vitreoretinal interface abnormality that
may be contributing to the macular
edema; presence of another ocular condition
that may affect the visual acuity or
macular edema during the course of the
study; evidence of neovascularization of
the iris or retina (presence of ischemic
CRVO); presence of substantial cataract,
one that might decrease the vision by
3 or more lines of vision at sometime
during the study; history of Grid/Focal
laser or Panretinal laser in the study eye;
history of vitreous surgery in the study
eye; history of use of intravitreal,
peribulbar, or retrobulbar steroids within
6 months of the study; history of
Cataract Surgery within 6 months of
enrollment; history of YAG capsulotomy
within 2 months of the surgery; visual
acuity <20/400 in the fellow eye; uncontrolled
glaucoma
Information: (805) 963-1648 x26
▪ Study: A Study of the Safety and
Efficacy of a New Treatment
for Macular Edema Resulting
From Retinal Vein Occlusion
Sponsor: Allergan
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy
of an intravitreal implant of dexamethasone
for the treatment of macular
edema associated with retinal vein
occlusion
Design: Treatment, Randomized, Double-
Blind, Dose Comparison, Parallel
Assignment, Safety/Efficacy Study
Number of Patients: 650
Inclusion Criteria: Eighteen years of age
or older with macular edema resulting
from retinal vein occlusion; decrease in
visual acuity in at least one eye as a
result of macular edema (20/50 or
worse); visual acuity in other eye no
worse than 20/200
Exclusion Criteria: Known anticipated
need for ocular surgery within next
12 months; history of glaucoma or current
high eye pressure requiring more
than 1 medication; diabetic retinopathy;
uncontrolled systemic disease; known
steroid-responder; use of systemic
steroids or warfarin/heparin
Information: clinicaltrials@allgeran.com
OTHER
▪ Study: Safety Study of Ranibizumab
Eye Injections to Treat
Choroidal Neovascularization
That Was Caused Other Than
by Age-Related Macular
Degeneration
Sponsor: Ophthalmic Consultants of
Boston/Genentech
Status: Currently enrolling
Purpose: To determine whether
ranibizumab is effective in the treatment
of choroidal neovascularization secondary
to causes other then wet macular
degeneration
Study Design: Treatment, Randomized,
Single-Blind, Dose Comparison, Factorial
Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Active CNV
pregnancy, agerelated
macular degeneration, current
eye infection or recent eye surgery, participating
in other eye studies
Information: (617) 573-1021
COMPLETED ENROLLMENT
▪ Study: Treatment of Patients
With Age-Related Macular
Degeneration With Anecortave
Acetate
Sponsor: University of Iowa
Information: http://www.clinicaltrials.gov/ct/show/NC
T00349739?order=1
▪ Study: Study of the Combination of
Anecortave Acetate and
Triamcinolone Acetonide for
the Treatment of Exudative
Age-Related Macular
Degeneration (AMD)
Sponsor: Alcon/Manhattan Eye, Ear &
Throat Hospital
Information: http://www.clinicaltrials.gov/ct/show/NC
T00211419?order=2
▪ Study: Identification and Treatment of
Feeder Vessels in AMD
Sponsor: NEI Information: http://www.clinicaltrials.gov/ct/show/NC
T00018070?order=1
▪ Study: Treatment of Diabetic Macular
Edema: Triamcinolone
Injections Vs. Laser
Photocoagulation
Sponsor: NEI
Information: http://www.clinicaltrials.
gov/ct/show/NCT00105404?order=2
▪ Study: Combination Bevacizumab and
Verteporfin in Neovascular AMD
Sponsor: Retinal Consultants Medical
Group
Information: http://www.clinicaltrials.
gov/ct/show/NCT00426998?order=1
▪ Study: Evaluation and Treatment of
Patients With Inherited Eye
Disease
Sponsor: NEI
Information: http://www.clinicaltrials.
gov/ct/show/NCT00011817?order=1
COMPLETED TRIALS
▪ Study: Comparison of Modified Early
Treatment Diabetic Retinopathy
Study and Mild Macular Grid
Laser Photocoagulation
Strategies for DME Sponsor: Diabetic Retinopathy Clinical
Research Network
Results: Available at http://www.ncbi.
nlm.nih.gov/entrez/query.fcgi?db=pubme
d&cmd=Retrieve&dopt=AbstractPlus&list_uids=17420366&query_hl=2&itool=pubme
d_DocSum
▪ Study: Diurnal Variation in Retinal
Thickening Measurement by OCT in
Center-involved DME
Sponsor: Diabetic Retinopathy Clinical
Research Network
Results: Available at http://www.ncbi.
nlm.nih.gov/entrez/
query.fcgi?db=pubmed&cmd=Retrieve&d
opt=AbstractPlus&list_uids=17159029&qu
ery_hl=4&itool=pubmed_docsum