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EFFICACY AND SAFETY OF TWO OR MORE DEXAMETHASONE INTRAVITREAL IMPLANT INJECTIONS FOR TREATMENT OF MACULAR EDEMA RELATED TO RETINAL VEIN OCCLUSION (SHASTA STUDY)

Capone, Antonio Jr MD*,†; Singer, Michael A. MD; Dodwell, David G. MD§; Dreyer, Richard F. MD; Oh, Kean T. MD**; Roth, Daniel B. MD††; Walt, John G. MBA‡‡; Scott, Lanita C. MD‡‡; Hollander, David A. MD, MBA‡‡

doi: 10.1097/IAE.0b013e318297f842
Original Study

Purpose: To evaluate the efficacy, safety, and reinjection interval of dexamethasone intravitreal implant (DEX implant) in branch retinal vein occlusion and central retinal vein occlusion patients receiving ≥2 DEX implant treatments.

Methods: Multicenter (26-site), retrospective chart review study. Data were collected from baseline (at first DEX implant) through 3 months to 6 months after last DEX implant.

Results: Patients (n = 289) received 2 to 9 (mean, 3.2) DEX implants as monotherapy (29.1% of patients) or with adjunctive treatments/procedures. Mean duration of macular edema before first DEX implant was 18.4 months. Mean reinjection interval was 5.6 months. Mean peak change in best-corrected visual acuity from baseline through 4 weeks to 20 weeks after final DEX implant was +1.0 line (P < 0.001). Best-corrected visual acuity and central retinal thickness improved significantly from baseline after each of the first 6 DEX implant injections (P ≤ 0.037); 59.7% of branch retinal vein occlusion and 66.7% of central retinal vein occlusion patients achieved ≥2-line best-corrected visual acuity improvement. Intraocular pressure increase (≥10 mmHg) occurred in 32.6% of patients; 29.1% used intraocular pressure-lowering medication to treat increases associated with DEX implant. Only 1.7% of patients required incisional glaucoma surgery.

Conclusion: Retinal vein occlusion patients treated with multiple DEX implant injections, either alone or combined with other therapies, had improved central retinal thickness and visual acuity with each subsequent injection. No new safety concerns developed with multiple implants.

In this multicenter, retrospective chart review study, 289 patients with retinal vein occlusion who received multiple treatments with dexamethasone intravitreal implant alone or in combination with other therapies showed improvement in central retinal thickness and visual acuity with each subsequent injection. No new safety concerns developed with multiple implants.

*Associated Retinal Consultants, Novi, Michigan;

Department of Ophthalmology, Oakland University, William Beaumont Hospital School of Medicine, Rochester, Michigan;

Medical Center Ophthalmology Associates, San Antonio, Texas;

§Illinois Retina Center, Springfield, Illinois;

Retina Northwest PC, Portland, Oregon;

**Associated Retinal Consultants, Traverse City, Michigan;

††Retina-Vitreous Center, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey;

‡‡Allergan, Inc, Irvine, California.

Reprint requests: John G Walt, MBA, Allergan, 2525 Dupont Dr, Irvine, CA 92612; e-mail: walt_john@allergan.com

Supported by Allergan, Inc.

The authors have no proprietary interest in dexamethasone intravitreal implant. J.G. Walt, L.C. Scott, and D.A. Hollander are employees of Allergan, Inc.

© 2014 by Ophthalmic Communications Society, Inc.