Objective:
To present the 3-year results of the phase 2 ALTITUDE study evaluating sura-vec in patients with nonproliferative diabetic retinopathy (NPDR).
Approach:
- Study Design: The ALTITUDE phase 2 trial randomized patients 3:1 to sura-vec vs observational control, focusing on dose level 3, which received a single injection of 1×10¹² genome copies/eye.
- Follow-up: Patients were followed until the primary endpoint at 1 year, with long-term follow-up available for those in the control group who could cross over.
Key Findings:
- In the control group, 42% of patients experienced a 2-step-or-greater worsening in their DRSS score, compared to 0% in dose levels 2 and 3.
- At year 3, 60% of patients in dose level 3 showed a 2-step-or-greater DRSS improvement.
- Patients in dose level 3 showed continued improvement at year 3 without further injections or vision-threatening events.
Limitations:
- The study included a limited number of patients (50 treated with sura-vec).
- There were no set retreatment criteria.
Conclusion:
Sura-vec demonstrates a strong safety profile and significant long-term efficacy in improving DRSS scores in NPDR patients.
Sources:
This content is an AI-generated, fully rewritten summary based on a published scholarly article. It does not reproduce the original text and is not a substitute for the original publication. Readers are encouraged to consult the source for full context, data, and methodology.