June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Prophylactic Ranibizumab for Exudative age-related macular degeneration (AMD) in Vulnerable Eyes with Non-Exudative AMD Trial (PREVENT): A prospective controlled clinical trial
Author Affiliations & Notes
  • Maziar Lalezary
    Southern California Desert Retina Consultants, Palm Desert, California, United States
    Doctor Retina, P.C., Beverly Hills, California, United States
  • Steven G. Lin
    Southern California Desert Retina Consultants, Palm Desert, California, United States
  • Clement K Chan
    Southern California Desert Retina Consultants, Palm Desert, California, United States
  • Bansal S. Alok
    Northern California Retina Vitreous Associates, Mountain View, California, United States
  • Rahul N Khurana
    Northern California Retina Vitreous Associates, Mountain View, California, United States
  • Mark Wieland
    Northern California Retina Vitreous Associates, Mountain View, California, United States
  • Louis K Chang
    Northern California Retina Vitreous Associates, Mountain View, California, United States
  • James Palmer
    Northern California Retina Vitreous Associates, Mountain View, California, United States
  • Prema Abraham
    Black Hills Regional Eye Institute, Rapid City, South Dakota, United States
  • Michael J Elman
    Elman Retina Group, Baltimore, Maryland, United States
  • Brandon J Lujan
    Northern California Retina Vitreous Associates, Mountain View, California, United States
  • Glenn Yiu
    Ophthalmology , UC Davis, Davis, California, United States
  • Footnotes
    Commercial Relationships   Maziar Lalezary, None; Steven Lin, Acucela (F), Allergan (F), Genentech-Roche (F), NEI (F), Ophthotec (F), Pfizer (F), Regeneron (F); Clement Chan, Acucela (F), Allergan (F), Allergan (C), Genentech-Roche (F), NEI (F), Ophtotech (F), Pfizer (F), Regeneron (F); Bansal Alok, None; Rahul Khurana, Allergan (C), Allergan (F), Clearside (F), Digisight (F), Genentech-Roche (C), Genentech-Roche (F), Regeneron (C), Regeneron (F), Santen (C), Santen (F); Mark Wieland, Alcon (C), Allergan (C), Compact Imaging (C), Genentech-Roche (C), Novartis (C), Zeiss (C); Louis Chang, None; James Palmer, None; Prema Abraham, Alcon (F), Allergan (F), Apellis (F), Genentech/Roche (F), Janssen Research and Development (F), Lexitas (F), OHR Pharmaceuticals (F), Ophthotech (F), Regeneron (F), Thrombogenics (F); Michael Elman, None; Brandon Lujan, Genentech-Roche (F), Genentech-Roche (C), UC Berkeley (P); Glenn Yiu, Alcon (F), Allergan (C), Carl Zeiss Meditec (C)
  • Footnotes
    Support  Genentech IST Grant
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 410. doi:
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    • Get Citation

      Maziar Lalezary, Steven G. Lin, Clement K Chan, Bansal S. Alok, Rahul N Khurana, Mark Wieland, Louis K Chang, James Palmer, Prema Abraham, Michael J Elman, Brandon J Lujan, Glenn Yiu; Prophylactic Ranibizumab for Exudative age-related macular degeneration (AMD) in Vulnerable Eyes with Non-Exudative AMD Trial (PREVENT): A prospective controlled clinical trial. Invest. Ophthalmol. Vis. Sci. 2017;58(8):410.

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      © ARVO (1962-2015); The Authors (2016-present)

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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.

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