Intravitreal Ranibizumab (Lucentis®) in the Treatment of Non-leaking Macular Cysts in Retinal Dystrophy
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
Publications
- Background Moustafa GA, Moschos MM. Intravitreal aflibercept (Eylea) injection for cystoid macular edema secondary to retinitis pigmentosa - a first case report and short review of the literature. BMC Ophthalmol. 2015 Apr 30;15:44. doi: 10.1186/s12886-015-0033-z.
- Background Artunay O, Yuzbasioglu E, Rasier R, Sengul A, Bahcecioglu H. Intravitreal ranibizumab in the treatment of cystoid macular edema associated with retinitis pigmentosa. J Ocul Pharmacol Ther. 2009 Dec;25(6):545-50. doi: 10.1089/jop.2009.0089.
- Background Yuzbasioglu E, Artunay O, Rasier R, Sengul A, Bahcecioglu H. Intravitreal bevacizumab (Avastin) injection in retinitis pigmentosa. Curr Eye Res. 2009 Mar;34(3):231-7. doi: 10.1080/02713680802710692.
- Background Miyata M, Oishi A, Oishi M, Hasegawa T, Ikeda HO, Tsujikawa A. Long-term efficacy and safety of anti-VEGF therapy in retinitis pigmentosa: a case report. BMC Ophthalmol. 2018 Sep 14;18(1):248. doi: 10.1186/s12886-018-0914-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetazolamide | Small molecule | 500 mg | Oral |
| Comparator | Brinzolamide | Small molecule | — | Topical |
| Subject | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |