Prophylactic Ranibizumab for Exudative age-related macular degeneration (AMD) in Vulnerable Eyes with Non-Exudative AMD Trial (PREVENT): A prospective controlled clinical trial

Abstract

Purpose : To report interim baseline demographics and results of the Prophylactic Ranibizumab for Exudative AMD in Vulnerable Eyes with Non-Exudative AMD Trial (PREVENT).

Methods : PREVENT is a multicenter, prospectively randomized, single-masked and controlled, interventional investigator sponsored phase I/II study of subjects with non-exudative AMD (NE-AMD) treated with 0.5 mg intravitreal ranibizumab (IVR) every 3 months for prophylaxis of exudative AMD (Ex-AMD) over 2 years. One-hundred eyes of 100 patients with high-risk NE-AMD in one eye (study eye) and history of Ex-AMD in the fellow eye will be randomized (1:1) to observation (OBS) or treatment (IVR). At baseline, all participants undergo evaluation by a retina specialist with ETDRS best-corrected visual acuity, intraocular pressure, exam, fundus photography, autofluorescence, fluorescein angiography (FA), spectral-domain optical coherence tomography (Cirrus SD-OCT, Carl Zeiss Meditec, Inc.) and genetic testing. Patients return every 3 months for exam and testing, adverse event monitoring and IVR only in the treatment group. The primary outcome measure is conversion to Ex-AMD as detect by examination, FA and/or OCT. Reading center evaluation of OCT parameters including drusen volume will be analyzed.

Results : Thirty-two (32) eyes with, 13 (40.6%) IVR and 19 (59.3%) OBS group, are reported in this interim analysis. All patients are Caucasian, 17 female, with mean age 77 and average baseline vision logMAR 0.14 (Snellen 20/25, 78 ETDRS letters). Baseline characteristics (age, gender, vision) were balanced between the two groups. Ten patients have completed the 2 year study. Three patients, all in the OBS group, converted to Ex-AMD at 1, 8 and 18 months. Seven patients (3 IVR, 4 OBS group) withdrew early from the study; 2 opted out by choice (OBS group), 1 relocated (IVR group) and 4 due to medical issues (2 OBS group). No ocular complications or adverse events were reported.

Conclusions : Interim analysis of PREVENT suggests that prophylactic anti-VEGF therapy (IVR) is tolerated well and may reduce the risk of Ex-AMD. This trend reinforces the hypothesis and warrants continued investigation as enrollment of the study is not complete and attrition has occurred. Continued follow-up of this cohort should provide further insight into the role of prophylactic IVR.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.