Removed since last issue:
Study: Optical Coherence Tomography Angiography (OCTA)–directed PDT Triple Therapy
https://www.clinicaltrials.gov/study/NCT04075136
Status: Suspended for deviations
Study: Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment
https://www.clinicaltrials.gov/study/NCT04707625
Status: Suspended for deviations
DRY AMD
NEW Study: HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
https://www.clinicaltrials.gov/study/NCT04566445
Sponsor: Gyroscope Therapeutics Limited
Purpose: The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 255
NEW Study: EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (EXPLORE)
https://www.clinicaltrials.gov/study/NCT04437368
Sponsor: Gyroscope Therapeutics Limited
Purpose: The purpose of this clinical study is to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 98
NEW Study: ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study (ORACLE)
https://www.clinicaltrials.gov/study/NCT05481827
Sponsor: Gyroscope Therapeutics Limited
Purpose: The purpose of this study is to evaluate the long-term safety of GT005 in participants with geographic atrophy (GA) secondary to AMD who have been treated in an antecedent study.
Design: Single group, no masking
Number of Patients: 225
NEW Study: FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD
https://www.clinicaltrials.gov/study/NCT03846193
Sponsor: Gyroscope Therapeutics Limited
Purpose: This is an open label first in human phase 1/2 multicenter study of GT005 in subjects with macular atrophy due to AMD.
Design: Nonrandomized, sequential assignment, no masking
Number of Patients: 56
Study: Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
https://www.clinicaltrials.gov/study/NCT06018558
Sponsor: Ocugen
Purpose: This is a phase 1/2 study to assess the safety and efficacy of OCU410 for geographic atrophy secondary to dry age-related macular degeneration (AMD).
Design: Randomized, sequential assignment, single masking
Number of Patients: 63
Information: umair.qazi@ocugen.com
Study: Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD)
https://www.clinicaltrials.gov/study/NCT05893537
Sponsor: Cognition Therapeutics
Purpose: This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 246
Information: clinicaltrials@cogrx.com
Study: A Multiple Dose Study of AVD-104 for Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (SIGLEC)
https://www.clinicaltrials.gov/study/NCT05839041
Sponsor: Aviceda Therapeutics, Inc.
Purpose: Investigate the safety, pharmacokinetics, and treatment effects of single and multi-dose of intravitreal AVD-104 in participants with geographic atrophy secondary to age-related macular degeneration.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 210
Information: dcallanan@avicedarx.com, marchitto@avicedarx.com
Study: QA102 Phase II Study in Subjects With Dry AMD (AMEND)
https://www.clinicaltrials.gov/study/NCT05536752
Sponsor: Smilebiotek Zhuhai Limited
Purpose: This is a phase 2, double-masked, randomized, placebo-controlled, dose-response study. The primary objective of the study is to evaluate the efficacy of QA102 oral capsules on the development of GA or CNV in high-risk eyes.
Design: Randomized, parallel assignment, triple masking
Number of Patients: 240
Information: jason.herter@ming-med.com
Study: A Study of Danicopan in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT0501952
Sponsor: Alexion Pharmaceuticals
Purpose: This is a dose-finding study designed to evaluate the efficacy, safety, and pharmacokinetics of danicopan in participants with GA secondary to AMD. The study consists of a screening Period of up to 4 weeks, a 104-week masked Treatment Period, followed by an Open-label Extension (OLE) Period starting at Week 104 and lasting for up to 1 year. This study will have 4 treatments arms: 100 milligrams (mg) twice daily (bid), 200 mg bid, 400 mg once daily (qd), and matching placebo.
Design: Randomized, parallel assignment, quadruple masked
Number of Patients: 330
Information: clinicaltrials@alexion.com
Study: A Masked, Placebo-controlled Study to Assess Iptacopan in Age-related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT05230537
Sponsor: Novartis Pharmaceuticals
Purpose: The purpose of this study is to assess the effect of Iptacopan (LNP023) to prevent conversion of early or intermediate age-related macular degeneration (AMD) eyes to new incomplete retinal pigment epithelium and outer retinal atrophy (iRORA) or late AMD.
Design: Randomized, parallel assignment, triple masked
Number of Patients: 146
Information: novartis.email@novartis.com
Study: Safety and Tolerability of RPESC-derived RPE Transplantation in Patients With Dry Age-related Macular Degeneration (AMD)
https://www.clinicaltrials.gov/study/NCT04627428
Sponsor: Luxa Biotechnology, LLC
Purpose: The main objective of the study is evaluation of the safety and tolerability of RPESC-RPE-4W as therapy for dry AMD.
Design: nonrandomized, sequential assignment, no masking
Number of Patients: 18
Information: jeffreystern@luxabiotech.com
Study: Study of Subretinal Implantation of Human Embryonic Stem Cell–derived RPE Cells in Advanced Dry AMD
https://www.clinicaltrials.gov/study/NCT02590692
Sponsor: Regenerative Patch Technologies, LLC
Purpose: The phase 1/2a clinical trial is designed to assess the feasibility of delivery and safety of human embryonic stem cell–derived RPE cells on a parylene membrane (CPCB-RPE1) in patients with advanced, dry age-related macular degeneration.
Design: Single group, no masking
Number of Patients: 16
Study: A Staged Study of the Safety and Effectiveness of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision due to Dry Age-related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT03178149
Sponsor: Astellas Institute for Regenerative Medicine
Purpose: This study is looking at a new treatment for slowing or reversing dry AMD, called ASP7317. ASP7317 is a specially created type of cells derived from stem cells. ASP7317 cells are injected into the macula of the eye. Immunosuppressive medicines (called IMT) are also taken around the time of injection of the cells to prevent the body from rejecting them.
Design: Randomized, parallel assignment, no masking
Number of Patients: 150
Information: astellas.registration@astellas.com
Study: Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated With AMD
https://www.clinicaltrials.gov/study/NCT02564978
Sponsor: National Eye Institute
Purpose: To see if minocycline is safe for people with GA and if it helps preserve their vision.
Design: Single group assignment, no masking, treatment
Number of Patients: 60
Information: Angela.kibiy@nih.gov
WET AMD
NEW Study: Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT06223958
Sponsor: Ocular Therapeutix, Inc.
Purpose: Study to evaluate the efficacy and safety of intravitreal OTX-TKI (axitinib implant) in subjects with neovascular age-related macular degeneration
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 300
Information: clinicalaffairs@ocutx.com
NEW Study: Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD) (DISCOVER)
https://www.clinicaltrials.gov/study/NCT05859776
Sponsor: AsclepiX Therapeutics, Inc.
Purpose: The goal of this clinical trial is to understand the safety of AXT107 injected suprachoroidally in participants with nAMD.
Design: Nonrandomized, sequential assignment, no masking
Number of Patients: 15
Information: amanda.bollino@lexitas.com
Study: Safety and Tolerability of KH631 Gene Therapy in Participants With Neovascular Age-related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT05657301
Sponsor: Chengdu Origen Biotechnology Co., Ltd.
Purpose: VAN-2201 is Phase I clinical trial to assess the safety and tolerability of KH631 in subjects with neovascular AMD. KH631 is gene therapy designed to deliver a protein which targets and blocks VEGF via an adeno-associated viral vector.
Design: Single group, no masking
Number of Patients: 25
Information: van2201@cnkh.com
Study: Study to Evaluate the Safety of CG-P5 Peptide Eye Drops in Patients Diagnosed With Age-related Wet Macular Degeneration
https://www.clinicaltrials.gov/study/NCT06132035
Sponsor: Caregen Co. Ltd.
Purpose: This will be a randomized, comparative, parallel, clinical study to assess initial safety and tolerability of CG-P5 peptide eye drops compared to placebo in patients diagnosed with age-related wet macular degeneration.
Design: Randomized, parallel assignment
Number of Patients: 45
Information: ishita.trivedi@cbcc.global
Study: Study of AR-14034 in Participants With Neovascular Age-Related Macular Degeneration (nAMD) (NOVA-1)
https://www.clinicaltrials.gov/study/NCT05769153
Sponsor: Aerie Pharmaceuticals
Purpose: The primary purpose of this study is to evaluate the safety and durability of single- and repeat administration of AR-14034 Sustained Release (SR) in subjects with neovascular age-related macular degeneration (nAMD).
Design: Randomized, parallel assignment
Number of Patients: 140
Information: alcon.medinfo@alcon.com
Study: A Phase 2 Study to Assess the Efficacy and Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT06116890
Sponsor: Kyowa Kirin, Inc.
Purpose: The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.
Design: Randomized, parallel assignment
Number of Patients: 180
Information: teppei.kurosawa.gx@kyowakirin.com
Study: Phase I/II Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity, and Pharmacokinetics of SKG0106 Intraocular Solution in Patients With Neovascular Age-related Macular Degeneration (nAMD)
https://www.clinicaltrials.gov/study/NCT05986864
Sponsor: Skyline Therapeutics (US) Inc.
Purpose: This is a phase 1/2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.
Design: Nonrandomized, single group, no masking
Number of Patients: 68
Information: yongqin.wang@skytx.com
Study: A Study of EXG102-031 in Patients With wAMD (Everest)
https://www.clinicaltrials.gov/study/NCT05903794
Sponsor: Exegenesis Bio
Purpose: EXG102-031 was made to block the extra vessel formation which would lead to less leakage affecting the vision. Before EXG102-031 can be tested for its efficacy (if it makes vision better), it must be tested to see if it is safely tolerated to confirm it can continue to be studied in more patients with nAMD.
Design: Sequential assignment, no masking
Number of Patients: 6
Information: quality-exg102-031@exegenesisbio.com
Study: Safety and Tolerability of OCU-10-C-110 for Injection in Subjects With Neovascular Age-related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT05904691
Sponsor: Ocugenix Corporation
Purpose: Multicenter, open-label, two-part safety assessment following administration of single ascending doses and repeat administration of the HTD of OCU-10-C-110 for injection in the study eye of participants with nAMD.
Design: Nonrandomized, single group, no masking
Number of Patients: 19
Information: sean@ocugenixtx.com
Study: A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD) (AMARONE)
https://www.clinicaltrials.gov/study/NCT05919693
Sponsor: EyeBiotech Ltd.
Purpose: EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.
Design: Randomized, sequential assignment, triple masking
Number of Patients: 92
Information: ClinicalInquiries@eyebiotech.com
Study: A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD
https://www.clinicaltrials.gov/study/NCT04740671
Sponsor: Shanghai Henlius Biotech
Purpose: This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD.
Design: Randomized, parallel assignment, double masked
Number of Patients: 388
Information: qi_jin@henlius.com
Study: Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration (ODYSSEY)
https://www.clinicaltrials.gov/study/NCT05891548
Sponsor: Clearside Biomedical, Inc.
Purpose: Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. Only one eye will be chosen as the study eye.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 60
Information: donna.bezner@clearsidebio.com
Study: Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy (RGX-314 SRLTFU)
https://www.clinicaltrials.gov/study/NCT03999801
Sponsor: Regenxbio Inc.
Purpose: This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314.
Design: Nonrandomized, single group assignment, no masking
Number of Patients: 865
Study: Effect of AIV007 by Periocular Administration in Subjects With nAMD or DME
https://www.clinicaltrials.gov/study/NCT05698329
Sponsor: AiViva BioPharma, Inc.
Purpose: To determine safety, pharmacokinetics, and duration of effect of periocularly administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).
Design: Nonrandomized, sequential assignment, no masking
Number of Patients: 30
Information: office@aiviva.com
Study: Evaluation of OLX10212 in Patients With Neovascular Age-related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT05643118
Sponsor: Olix Pharmaceuticals, Inc.
Purpose: This is a phase 1, multicenter, open-label, single- and multi-dose, dose-escalating study of OLX10212 in patients with neovascular age-related macular degeneration (AMD).
Design: Nonrandomized, sequential assignment, no masking
Number of Patients: 60
Information: yikim@olixpharma.com
Study: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Subjects With Neovascular (Wet) Age-related Macular Degeneration (AMD) or Subjects With Diabetic Macular Edema (DME) (Tejas)
https://www.clinicaltrials.gov/study/NCT05387837
Sponsor: Ashvattha Therapeutics, Inc.
Purpose: A study to evaluate the safety, tolerability, and pharmacokinetics of D-4517.2 after subcutaneous administration in subjects with neovascular (wet) age-related macular degeneration (AMD) or subjects with diabetic macular edema (DME).
Design: Nonrandomized, parallel assignment, no masking
Number of Patients: 30
Information: bella@attx.com
Study: Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)
https://www.clinicaltrials.gov/study/NCT05407636
Sponsor: Regenxbio Inc.
Purpose: RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD).
Design: Randomized, parallel assignment, single masking
Number of Patients: 465
Information: Patientadvocacy@regenxbio.com
Study: Study of EYP-1901 in Subjects With Wet Age-related Macular Degeneration (wAMD)
https://www.clinicaltrials.gov/study/NCT05381948
Sponsor: EyePoint Pharmaceuticals, Inc.
Purpose: This is a phase 2 randomized, double-masked study comparing the efficacy of EYP-1901 at 2 dose levels: 2060 µg and 3090 µg against aflibercept.
Design: Randomized, parallel assignment, triple masking
Number of Patients: 150
Information: dpaggiarino@eyepointpharma.com
Study: Safety and Efficacy of ADVM-022 in Treatment-experienced Patients With Neovascular Age-related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT05536973
Sponsor: Adverum Biotechnologies, Inc.
Purpose: ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.
Design: Randomized, parallel assignment
Number of Patients: 72
Prior treatment with gene therapy.
Information: LUNA-Clinops@adverum.com
Study: Safety and Efficacy of AM712 in Patients With nAMD
https://www.clinicaltrials.gov/study/NCT05345769
Sponsor: AffaMed Therapeutics (US) Inc.
Purpose: The purpose of this phase 1 study is comprised of multiple ascending-dose component (part 1) and dose-expansion cohorts component (part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age-related macular degeneration (nAMD).
Design: Single group, open label
Number of Patients: 24
Information: fan.yang@affamed.com
Study: Study Evaluating the Treatment of OTX-TKI for Subjects With Neovascular Age-related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT04989699
Sponsor: Ocular Therapeutix, Inc.
Purpose: Evaluate the safety, tolerability, and efficacy of OTX-TKI for intravitreal use in subjects with neovascular age-related macular degeneration.
Design: Randomized, parallel assignment, triple masked
Number of Patients: 20
Information: clinicalaffairs@ocutx.com
Study: 4D-150 in Patients With Neovascular (Wet) Age-related Macular Degeneration
https://www.clinicaltrials.gov/study/NCT05197270
Sponsor: 4D Molecular Therapeutics
Purpose: Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment.
Design: Randomized, sequential assignment
Number of Patients: 65
Information: clinicaltrials@4DMT.com
Study: A 3-month Study to Compare the Safety of ONS-5010 in Vials vs Prefilled Syringe in Subjects With Visual Impairment due to Retinal Disorders (NORSE SEVEN)
https://www.clinicaltrials.gov/study/NCT05112861
Sponsor: Outlook Therapeutics, Inc.
Purpose: The study will compare the safety of ophthalmic bevacizumab in vials vs prefilled syringes in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.
Design: Randomized, parallel assignment
Number of Patients: 120
Study: A Study of the Efficacy and Safety of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration Previously Treated With Intravitreal Agents Other Than Ranibizumab (Belvedere)
https://www.clinicaltrials.gov/study/NCT04853251
Sponsor: Genentech Inc.
Purpose: Study ML43000 is a phase 3b/4 multicenter, open-label (visual assessor-masked) study designed to assess the efficacy and safety of PDS 100 mg/mL Q24W in patients with nAMD who have been previously treated with anti-VEGF agents other than ranibizumab. Approximately 200 patients will be enrolled at approximately 40 sites.
Design: Single group assignment, no masking
Number of Patients: 200
Information: global-roche-genentech-trials@gene.com
Study: RGX-314 Gene Therapy Pharmacodynamic Study for Neovascular Age-related Macular Degeneration (nAMD)
https://www.clinicaltrials.gov/study/NCT04832724
Sponsor: Regenxbio Inc.
Purpose: RGX-314 is a gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein. RGX-314 is being studied for its potential to have a single injection that could allow the eye to make its own supply of anti-VEGF continually. The purpose of this phase 2, open label study is to evaluate whether different doses of RGX-314 from 2 different formulations (clinical vs eventual commercial formulation) perform the same in humans when delivered by subretinal administration.
Design: Nonrandomized, sequential assignment, no masking
Number of Patients: 60
Information: patientadvocacy@regenxbio.com
Study: OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD) (ShORe)
https://www.clinicaltrials.gov/study/NCT04757610
Sponsor: Opthea Limited
Purpose: A 2-year, phase 3, multicenter, randomized, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at week 52.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 990
Information: info@opthea.com
Study: OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD) (COAST)
https://www.clinicaltrials.gov/study/NCT04757636
Sponsor: Opthea Limited
Purpose: A 2-year phase 3, multicenter, randomized, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at week 52.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 990
Information: info@opthea.com
Study: A Study to Evaluate the Long-term Safety and Tolerability of Faricimab in Participants With Neovascular Age-related Macular Degeneration (AVONELLE-X)
https://www.clinicaltrials.gov/study/NCT04777201
Sponsor: Hoffmann-La Roche
Purpose: This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab 6 mg administered by intravitreal injection at a personalized treatment interval to participants with neovascular age-related macular degeneration who enrolled in and completed one of the phase 3 studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies.
Design: Single group, no masking
Number of Patients: 1,280
Information: global-roche-genentech-trials@gene.com
Study: Pivotal 1 Study of RGX-314 Gene Therapy in Participants With nAMD (ATMOSPHERE)
https://www.clinicaltrials.gov/study/NCT04704921
Sponsor: Regenxbio Inc.
Purpose: This randomized, partially masked, controlled, phase 2b/3 clinical study will evaluate the efficacy and safety of RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of RGX-314 relative to an active comparator. The primary endpoint of this study is mean change in best-corrected visual acuity (BCVA) of RGX-314 relative to ranibizumab. Approximately 300 participants who meet the inclusion/exclusion criteria will be enrolled into one of 3 arms.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 300
Information: patientadvocacy@regenxbio.com
Study: MMP-9 Inhibition for Recalcitrant Wet AMD
https://www.clinicaltrials.gov/study/NCT04504123
Sponsor: University of Iowa
Purpose: The investigators plan to evaluate the effect of oral doxycycline vs placebo on the anatomic and functional outcomes in persistent subretinal eye fluid in neovascular wet age-related macular degeneration. This subset are incomplete or nonresponders to current anti-VEGF intravitreal therapy.
Design: Randomized, parallel assignment
Number of Patients: 50
Information: elliott-sohn@uiowa.edu
Study: RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-related Macular Degeneration (nAMD) (AAVIATE)
https://www.clinicaltrials.gov/study/NCT04514653
Sponsor: Regenxbio Inc.
Purpose: RGX-314 is being developed as a novel one-time gene therapy treatment for the treatment of neovascular (wet) age-related macular degeneration (wet AMD).
Design: Randomized, sequential assignment, no masking
Number of Patients: 40
Information: patientadvocacy@regenxbio.com
Study: Study to Gather Information on Safety and Use of High-dose Aflibercept Injection Into the Eye in Patients With an Age-related Eye Disorder That Causes Blurred Vision or a Blind Spot due to Abnormal Blood Vessels That Leak Fluid Into the Light Sensitive Lining Inside the Eye (PULSAR)
https://www.clinicaltrials.gov/study/NCT04423718
Sponsor: Bayer
Purpose: In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high-dose treatment with aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD).
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 960
Information: clinical-trials-contact@bayer.com
Study: NEAMES: Episcleral Brachytherapy for the Treatment of Wet AMD
https://www.clinicaltrials.gov/study/NCT02988895
Sponsor: Salutaris Medical Devices, Inc.
Purpose: This is a prospective, single-arm, open-label, safety, usability, and tolerability trial of Strontium 90 (Sr90) beta radiation episcleral brachytherapy in subjects receiving aflibercept therapy pro re nata (PRN) for the treatment of early neovascular age-related macular degeneration (nAMD) lesions. Secondary aims are to observe clinical outcomes of area of leakage, subretinal fluid, lesion size, visual acuity, and anti–vascular endothelial growth factor (anti-VEGF) treatment burden.
Design: Single Group, No Masking, Treatment
Number of Patients: 20
Information: mdrew@salutarismd.com
DIABETIC MACULAR EDEMA
NEW Study: Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2)
https://www.clinicaltrials.gov/study/NCT06172257
Sponsor: Oculis
Purpose: The primary objective is to evaluate the efficacy and safety of OCS 01 as compared to Vehicle in subjects with diabetic macular edema.
Design: Single group, no masking
Number of Patients: 350
Information: info@oculis.com
NEW Study: Safety and Effect of Intravitreal Injection of a Derivative of Nucleoside Reverse Transcriptase Inhibitor in Subjects With Diabetic Macular Edema
https://www.clinicaltrials.gov/study/NCT05699759
Sponsor: Michelle Abou-Jaoude
Purpose: This study is designed to assess the safety and initial evidence of efficacy of the novel compound SOM-401 (K8), a derivative of a nucleoside reverse transcriptase inhibitor, in subjects with untreated, clinically significant, diabetic macular edema (DME).
Design: Single group, no masking
Number of Patients: 5
Information: sara.kuhl@uky.edu
NEW Study: A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema
https://www.clinicaltrials.gov/study/NCT05699759
Sponsor: Aviceda Therapeutics, Inc.
Purpose: A phase 2 study to determine the safety and preliminary efficacy of intravitreal injections of AVD-104, a novel glyco-mimetic nanoparticle, in reducing macular edema associated with diabetic retinopathy.
Design: Randomized, parallel assignment, double masking
Number of Patients: 30
Information: dcallanan@avicedarx.com
Study: A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema
https://www.clinicaltrials.gov/study/NCT04005430
Sponsor: Targeted Therapy Technologies, LLC
Purpose: This phase 1 trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.
Design: Single group, no masking
Number of Patients: 1
Study: A Phase 2 Study to Assess the Efficacy and Safety of KHK4951 in Patients With Diabetic Macular Edema
https://www.clinicaltrials.gov/study/NCT06116916
Sponsor: Kyowa Kirin, Inc.
Purpose: The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
Design: Randomized, parallel assignment
Number of Patients: 150
Information: teppei.kurosawa.gx@kyowakirin.com
Study: 4D-150 in Patients With Diabetic Macular Edema
https://www.clinicaltrials.gov/study/NCT05930561
Sponsor: 4D Molecular Therapeutics
Purpose: Phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with diabetic macular edema (DME).
Design: Randomized, parallel assignment, double masking
Number of Patients: 72
Information: clinicaltrials@4DMT.com
Study: Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
https://www.clinicaltrials.gov/study/NCT06011798
Sponsor: Unity Biotechnology, Inc.
Purpose: The goal of this clinical trial is to assess the efficacy and safety of multiple doses of foselutoclax (UBX1325) in patients with diabetic macular edema. The main question(s) the study aims to answer are: assess the efficacy of foselutoclax compared to aflibercept; and assess the safety and tolerability of foselutoclax.
Design: Randomized, parallel assignment, triple masking
Number of Patients: 40
Information: UBX1325_medicalmonitor@unitybiotechnology.com
Study: Evaluation of Tonabersat for DME (AN)
https://www.clinicaltrials.gov/study/NCT05727891
Sponsor: Jaeb Center for Health Research
Purpose: This randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 128
Information: drcrnet@jaeb.org
Study: Treat & Extend Versus Fixed Dosing With Faricimab for Management of Diabetic Macular Edema: A Pragmatic, Multi-center, Open-label, Randomized, Controlled Trial (INSITE-DME)
https://www.clinicaltrials.gov/study/NCT05610319
Sponsor: McMaster University
Purpose: This study will assess a pragmatic, treat and extend regimen of faricimab against the standard of a fixed dosing regimen.
Design: Randomized, parallel assignment, single masking
Number of Patients: 446
Information: delfabbg@mcmaster.ca
Study: Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex in the Treatment of Diabetic Macular Edema (OXEYE)
https://www.clinicaltrials.gov/study/NCT05697809
Sponsor: Oxular Limited
Purpose: The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres) using the Oxulumis illuminated microcatheterization device compared with intravitreal dexamethasone implant (Ozurdex) in subjects with diabetic macular edema.
Design: Randomized, parallel assignment, triple masking
Number of Patients: 128
Information: clinicaltrials@oxular.com
Study: A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD) (AMARONE)
https://www.clinicaltrials.gov/study/NCT05919693
Sponsor: EyeBiotech Ltd.
Purpose: EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.
Design: Randomized, sequential assignment, triple masking
Number of Patients: 92
Information: ClinicalInquiries@eyebiotech.com
Study: Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema (PRECISION)
https://www.clinicaltrials.gov/study/NCT04411693
Sponsor: The Cleveland Clinic/Allergan
Purpose: This study is an interventional, prospective randomized study comparing the dexamethasone implant to intravitreal aflibercept. Subjects will have an initial single injection of aflibercept and will be randomized if diabetic macular edema persists. Each subject will be evaluated for 6 months following randomization. Thus, the study duration will be 12 months plus the recruitment period.
Design: Randomized, parallel assignment, no masking
Number of Patients: 23
Information: Justis Ehlers, The Norman C. and Donna L. Harbert Endowed Chair of Ophthalmic Research, The Cleveland Clinic
Study: Oxulumis Suprachoroidal Microcatherization of Triesence in Diabetic Macular Edema (CAPE)
https://www.clinicaltrials.gov/study/NCT05512962
Sponsor: Oxular Limited
Purpose: The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis device for a randomized treatment with two dose levels of Triesence in subjects with Diabetic Macular Edema.
Design: Randominzed, parallel assignment, single masking
Number of Patients: 20
Information: clinicaltrials@oxular.com
Study: Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME)
https://www.clinicaltrials.gov/study/NCT05712720
Sponsor: Rezolute
Purpose: The objective of this trial is to assess the safety, efficacy, and tolerability of RZ402 in patients with diabetic macular edema.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 100
Information: RZ402clinicaltrials@rezolutebio.com
Study: Effect of AIV007 by Periocular Administration in Subjects With nAMD or DME
https://www.clinicaltrials.gov/study/NCT05698329
Sponsor: AiViva BioPharma, Inc.
Purpose: To determine safety, pharmacokinetics, and duration of effect of periocularly administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).
Design: Nonrandomized, sequential assignment, no masking
Number of Patients: 30
Information: office@aiviva.com
Study: The Study of CU06-1004 in Patients With Diabetic Macular Edema (DME)
https://www.clinicaltrials.gov/study/NCT05573100
Sponsor: Curacle Co., Ltd.
Purpose: This phase 2a trial is a randomized, open-label, parallel-group study in approximately 60 patients with DME to evaluate the efficacy and safety of CU06-1004 orally administered once daily for 12 weeks. The study will have a 1:1:1 randomization (CU06-1004 100mg: CU06-1004 200mg: CU06-1004 300mg).
Design: Randomized, parallel assignment, no masking
Number of Patients: 60
Information: christinelee@kcrnresearch.com
Study: Phase 2 Spectra Study to Evaluate the Safety and Efficacy of OPL-0401 in Patients With Diabetic Retinopathy
https://www.clinicaltrials.gov/study/NCT05393284
Sponsor: Valo Health, Inc.
Purpose: OPL-0401-201 is a multicenter study to investigate the efficacy and safety of OPL-0401 in patients with diabetes mellitus (DM) with diabetic retinopathy.
Design: Randomized, parallel assignment, triple masking
Number of Patients: 120
Study: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Subjects With Neovascular (Wet) Age-related Macular Degeneration (AMD) or Subjects With Diabetic Macular Edema (DME) (Tejas)
https://www.clinicaltrials.gov/study/NCT05387837
Sponsor: Ashvattha Therapeutics, Inc.
Purpose: A study to evaluate the safety, tolerability, and pharmacokinetics of D-4517.2 after subcutaneous administration in subjects with neovascular (wet) age-related macular degeneration (AMD) or subjects with diabetic macular edema (DME).
Design: Nonrandomized, parallel assignment, no masking
Number of Patients: 30
Information: bella@attx.com
Study: AG-73305 Single Ascending-dose Cohort Study in DME
https://www.clinicaltrials.gov/study/NCT05301751
Sponsor: Allgenesis Biotherapeutics Inc.
Purpose: This is a multicentered, open-labeled, single ascending-dose cohort study to evaluate 4 dosing cohorts of AG-73305 administered by intravitreal injection in patients with diabetic macular edema (DME).
Design: Nonrandomized, sequential assignment, no masking
Number of Patients: 25
Information: tan.nguyen@allgenesis.com
Study: A Study to investigate RO7200220 in Diabetic Macular Edema
https://www.clinicaltrials.gov/study/NCT05151731
Sponsor: Hoffmann-La Roche
Purpose: Study BP43445 is a phase 2, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7200220 administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 52 weeks.
Design: Randomized, parallel assignment, triple masking
Number of Patients: 320
Information: global-roche-genentech-trials@gene.com
Study: A Study to Investigate RO7200220 in Combination With Ranibizumab in Diabetic Macular Edema
https://www.clinicaltrials.gov/study/NCT05151744
Sponsor: Hoffmann-La Roche
Purpose: Study BP43464 is a phase 2, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of RO7200220 in combination with anti–vascular endothelial growth factor (VEGF) inhibitor ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 52 weeks.
Design: Randomized, parallel assignment, triple masking
Number of Patients: 160
Information: global-roche-genentech-trials@gene.com
Study: A Study to Investigate Faricimab Treatment Response in Treatment-naïve, Underrepresented Patients With Diabetic Macular Edema
https://www.clinicaltrials.gov/study/NCT05224102
Sponsor: Genentech, Inc.
Purpose: This phase 4 study is designed to investigate treatment response in treatment-naïve underrepresented patients with diabetic macular edema (DME) who are treated with faricimab. The study population will consist of participants ≥18 years of age who self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander.
Design: Single group, no masking
Number of Patients: 120
Information: global-roche-genentech-trials@gene.com
Study: Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Diabetic Macular Edema
https://www.clinicaltrials.gov/study/NCT05066997
Sponsor: Oculis
Purpose: The purpose of this study is to evaluate the efficacy and safety of OCS-01 ophthalmic suspension vs vehicle alone in subjects with DME.
Design: Randomized, parallel assignment, double masking
Number of Patients: 482
Information: naleni.eigensatz@oculis.com
Study: A Study of Intravitreal ILUVIEN Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME) (NEW DAY)
https://www.clinicaltrials.gov/study/NCT04469595
Sponsor: Alimera Sciences
Purpose: This is a randomized, masked, active-controlled, parallel-group, multicenter study that will assess the efficacy of ILUVIEN as a baseline therapy in the treatment of center-involving DME (CI-DME).
Design: randomized, parallel assignment, double masking
Number of Patients: 300
Information: rachel.nelson@alimerasciences.com
Study: RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) Without Center-involved Diabetic Macular Edema (CI-DME) (ALTITUDE)
https://www.clinicaltrials.gov/study/NCT04567550
Sponsor: Regenxbio Inc.
Purpose: RGX-314 is being developed as a novel one-time gene therapy treatment for the treatment of diabetic retinopathy, a chronic and progressive complication of diabetes mellitus.
Design: Randomized, parallel assignment, no masking
Number of Patients: 40
Information: patientadvocacy@regenxbio.com
Study: Study of a High-dose Aflibercept in Participants With Diabetic Eye Disease (PHOTON)
https://www.clinicaltrials.gov/study/NCT04429503
Sponsor: Regeneron Pharmaceuticals
Purpose: The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides noninferior best-corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 640
Information: clinicaltrials@regeneron.com
Study: A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema to Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered via the Port Delivery System Relative to the Comparator Arm (PAVILION)
https://www.clinicaltrials.gov/study/NCT04503551
Sponsor: Hoffmann-La Roche
Purpose: Study GR41675 is a multicenter, randomized study in participants with diabetic retinopathy without center-involved diabetic macular edema to evaluate the efficacy and safety of the port delivery system with ranibizumab (PDS) relative to the comparator arm.
Design: Randomized, parallel assignment, single masking
Number of Patients: 160
Information: global.rochegenentechtrials@roche.com
Study: Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema (PRECISION)
https://www.clinicaltrials.gov/study/NCT04411693
Sponsor: The Cleveland Clinic
Purpose: This study is an interventional, prospective randomized study comparing the dexamethasone implant to intravitreal aflibercept. Subjects will have an initial single injection of aflibercept and will be randomized if diabetic macular edema persists. Each subject will be evaluated for 6 months following randomization. Thus, the study duration will be 12 months plus the recruitment period.
Design: Randomized, parallel assignment, no masking
Number of Patients: 50
Information: ehlersj@ccf.org
Study: This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) Compared with Intravitreal Ranibizumab (Pagoda)
https://www.clinicaltrials.gov/study/NCT04108156
Sponsor: Hoffmann-La Roche
Purpose: This study will evaluate the efficacy, safety, and pharmacokinetics of the PDS in participants with diabetic macular edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).
Design: Randomized, parallel assignment, single masking
Number of Patients: 545
Information: global-roche-genentech-trials@gene.com
Study: Steroid vs Anti–Vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification (STAMP)
https://www.clinicaltrials.gov/study/NCT03832179
Sponsor: Bay Area Retina Associates
Purpose: The primary objective of this study is to compare the efficacy of antecedent intravitreal anti–vascular endothelial growth factor therapy vs Ozurdex in reducing postcataract surgery-related macular edema in patients with pre-existing diabetic macular edema.
Design: Randomized, parallel assignment, no masking
Number of Patients: 32
Information: cluo@bayarearetina.com, fahmed@bayarearetina.com
RETINAL VEIN OCCLUSION
NEW Study: Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
https://www.clinicaltrials.gov/study/NCT01736059
Sponsor: University of California, Davis
Purpose: This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.
Design: Single group, no masking
Number of Patients: 15
Study: Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
https://www.clinicaltrials.gov/study/NCT04120311
Sponsor: Targeted Therapy Technologies, LLC
Purpose: This phase 1 trial will assess primarily the safety and secondarily anti-inflammatory effect of episcleral dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.
Design: Single group, no masking
Number of Patients: 2
Study: A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion) (QUASAR)
https://www.clinicaltrials.gov/study/NCT05850520
Sponsor: Bayer
Purpose: A study to learn how well a higher amount of aflibercept given as an injection into the eye works and how safe it is in people with reduced vision due to swelling in the macula, central part of the retina caused by a blocked vein in the retina (macula edema secondary to retinal vein occlusion) (QUASAR)
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 822
Information: clinical-trials-contact@bayer.com
Study: Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Retinal Vein Occlusion
https://www.clinicaltrials.gov/study/NCT05532735
Sponsor: Annexin Pharmaceuticals AB
Purpose: Randomized, double-masked placebo-controlled study to evaluate safety and proof of concept with ascending doses of ANXV (human recombinant Annexin A5 protein) during 5 consecutive days treatment in patients recently diagnosed with retinal vein occlusion.
Design: Randomized, sequential assignment, quadruple masking
Number of Patients: 28
Information: anna.frostegard@annexinpharma.com
Study: Phase 1 Study of Episcleral Celecoxib for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole
https://www.clinicaltrials.gov/study/NCT04120636
Sponsor: Targeted Therapy Technologies, LLC
Purpose: This phase 1 trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid, and vitreous.
Design: Single group, no masking
Number of Patients: 3
Study: Treatment of Central Retinal Vein Occlusion Using Stem Cells Study (TRUST)
https://www.clinicaltrials.gov/study/NCT03981549
Sponsor: The Emmes Company, LLC
Purpose: This study evaluates whether intravitreal autologous CD34+ stem cell therapy is safe, feasible and potentially beneficial in eyes with vision loss from central retinal vein occlusion (CRVO). Half of the participants will receive immediate cellular therapy followed by sham therapy 6 months later, while the other half will receive immediate sham therapy followed by cellular therapy 6 months later. Participants will be followed for a total of 2 years.
Design: Randomized, parallel assignment, triple masking
Number of Patients: 20
Information: dcmacias@ucdavis.edu, mesalvador@ucdavis.edu
UVEITIS
Study: Adalimumab in JIA-associated Uveitis Stopping Trial (ADJUST)
https://www.clinicaltrials.gov/study/NCT03816397
Sponsor: Nisha Acharya
Purpose: The proposed study is a stratified, block-randomized, double-masked, controlled trial to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU).
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 118
Information: nisha.acharya@ucsf.edu
Study: POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU (OPTYK-1)
https://www.clinicaltrials.gov/study/NCT05953688
Sponsor: Alumis Inc
Purpose: This is a multi-center, randomized, double-masked, proof-of-concept study in patients with active noninfectious intermediate, posterior, or panuveitis.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 30
Information: clinicaltrials@alumis.com
Study: Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema (LEOPARD)
https://www.clinicaltrials.gov/study/NCT05608837
Sponsor: Quan Dong Nguyen/Global Ophthalmic Research Center (GORC) and Oculis
Purpose: The goal of the LEOPARD clinical trial is to investigate a new kind of steroid eye drops, OCS-01. In the LEOPARD study the investigators wish to see how safe the study drug (OCS-01) is and how well it works, in resolving the fluid collection in the eye in patients with Uveitis or in patients who have had eye surgery.
Design: Randomized, parallel assignment, double masking
Number of Patients: 24
Information: leopardme@stanford.edu
Study: A Study of Brepocitinib in Adults With Active Noninfectious Nonanterior Uveitis (NEPTUNE)
https://www.clinicaltrials.gov/study/NCT05523765
Sponsor: Priovant Therapeutics, Inc.
Purpose: This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with active, noninfectious intermediate, posterior, or panuveitis (NIU).
Design: Randomized, parallel assignment, triple masking
Number of Patients: 24
Information: NeptuneStudyManager@priovanttx.com
Study: Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Noninfectious Posterior Segment Uveitis
https://www.clinicaltrials.gov/study/NCT05322070
Sponsor: Eyepoint Pharmaceuticals, Inc.
Purpose: A study to evaluate the safety and efficacy of Yutiq 0.18 mg intravitreal implant for the management of chronic noninfectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy.
Design: Single group, no masking
Number of Patients: 125
Information: tejas.shah@cbcc.global
Study: The Use of 2 YUTIQ vs Sham for Treatment of Chronic Noninfectious Intraocular Inflammation Affecting the Posterior Segment (TYNI)
https://www.clinicaltrials.gov/study/NCT05486468
Sponsor: Texas Retina Associates
Purpose: In this study, we aim to compare the recurrence rate of uveitis by month 6 of 2 Yutiq intravitreal implants to sham.
Design: Randomized, parallel assignment, double masking
Number of Patients: 30
Information: tkeesling@texasretina.com
Study: Phase 2b Pivotal Study of Izokibep in Noninfectious Intermediate-, Posterior-, or Pan-uveitis
https://www.clinicaltrials.gov/study/NCT05384249
Sponsor: Acelyrin Inc.
Purpose: Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin-17A, to which it binds with high affinity. Izokibep has been investigated in nonclinical and clinical studies including healthy subjects and patients with psoriasis and psoriatic arthritis and is currently being studied in uveitis, axial spondyloarthritis, and hidradenitis suppurativa. This study investigates izokibep in subjects with active noninfectious intermediate-, posterior-, or panuveitis requiring high-dose steroids.
Design: Randomized, parallel assignment, double masking
Number of Patients: 120
Information: clinicaltrials@acelyrin.com
Study: Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes (STACCATO)
https://www.clinicaltrials.gov/study/NCT03586284
Sponsor: University of California, San Francisco
Purpose: A double-masked randomized controlled clinical trial comparing the efficacy of oral valganciclovir, topical ganciclovir 2%, and placebo for the treatment of PCR-proven CMV anterior uveitis. This pilot study will provide valuable information concerning the treatment of CMV anterior uveitis with oral and topical medications, including effective concentrations and side-effect profile. The information obtained from this study will help inform future larger clinical trials in CMV anterior uveitis.
Design: Randomized, parallel assignment, quadruple masking
Number of Patients: 99
Information: john.gonzales@ucsf.edu
Study: Adalimumab vs Conventional Immunosuppression for Uveitis Trial (ADVISE)
https://www.clinicaltrials.gov/study/NCT03828019
Sponsor: JHSPH Center for Clinical Trials
Purpose: The ADVISE Trial is a multicenter randomized, parallel-treatment, comparative effectiveness trial comparing adalimumab to conventional (small molecule) immunosuppression for corticosteroid spring in the treatment of noninfectious, intermediate, posterior, and panuveitides.
Design: Randomized, parallel assignment, no masking
Number of Patients: 222
Information: jholbro1@jhu.edu, esugar2@jhu.edu
