drugset / Trial / NCT03763227

Intravitreal Ranibizumab (Lucentis®) in the Treatment of Non-leaking Macular Cysts in Retinal Dystrophy

NCT03763227

Phase 2 Completed 13 enrolled Sultan Qaboos University
Non-randomizedSequentialOpen-labelTreatment

Summary

To evaluate the efficacy and safety of intravitreal ranibizumab (IVR) injection in the treatment of non-leaking macular cysts in patients with retinal dystrophy. Material and Methods: Design - Prospective, nonrandomized, nonblinded, clinical trial. Participants - Patients \>18 years diagnosed with retinal dystrophies and non-leaking macular cysts between Jan 2015 and July 2018 in 1 center. Methods - Phase 1: Patients with best corrected visual acuity (BCVA) \< 0.5 will receive carbonic anhydrase inhibitors (CAI) \[oral acetazolamide 500mg/day or topical brinzolamide twice daily\] and followed up for three months. Phase 2: Patients who do not show an adequate response with CAI will receive three 0.5mg IVR injection at monthly intervals. Outcome - 1) Significant reduction (\> 10%) of the central macular thickness (CMT), 2) Improvement (\> 1 line) in BCVA 3) Presence of any complication.

Timeline

Start
2015-07-24
Primary completion
2019-08-29
Completion
2019-08-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetazolamide Small molecule 500 mg Oral
Comparator Brinzolamide Small molecule Topical
Subject Ranibizumab Monoclonal antibody 0.5 mg Intravitreal