Macular Degeneration: Weinberg DV

Williams GA, Haller JA, Kuppermann BD, Blumenkranz MS, Weinberg DV, Chou C, Whitcup SM, Anonymous00096. · Beaumont Eye Institute, Royal Oak, Michigan, USA. · Am J Ophthalmol. · Pubmed #19268890 No free full text.

Abstract: PURPOSE: To evaluate the effects of a dexamethasone intravitreous drug delivery system (dexamethasone DDS) in patients with persistent macular edema (ME) resulting from uveitis or Irvine-Gass syndrome. DESIGN: Randomized, prospective, single-masked, controlled trial. METHODS: Three hundred and fifteen patients with persistent (>or= 90 days) ME were randomized in a multicenter study to surgical placement of 350 or 700 microg dexamethasone DDS or observation. This study evaluated the subset of patients with uveitis or Irvine-Gass syndrome (n = 41). The primary outcome measure was the proportion of patients achieving a 10-letter or more improvement in best-corrected visual acuity (BCVA) at day 90. Change in fluorescein angiographic leakage and safety also were evaluated. RESULTS: At day 90, a 10-letter or more BCVA improvement was seen in 41.7% (5/12) of patients in the 350-microg group, in 53.8% (7/13) of patients in the 700-microg group, and in 14.3% (2/14) of patients in the observation group (P = .029 vs the 700-microg group). Improvement in visual acuity persisted to day 180. A 15-letter or more improvement was achieved in 53.8% (7/13) of 700-microg patients vs 7.1% (1/14) of observed patients (P = .008). There were significantly greater reductions in fluorescein leakage in treated patients than in observed patients. Dexamethasone DDS was well tolerated. Throughout the study, an increase in intraocular pressure of 10 mm Hg or more was seen in 5 of 13 patients in the 700-microg group, in 1 of 12 patients in the 350-microg group, and in no patients in the observation group. There were no reports of endophthalmitis. CONCLUSIONS: In patients with persistent ME resulting from uveitis or Irvine-Gass syndrome, 700-microg dexamethasone DDS was well tolerated and produced statistically significant improvements in visual acuity and fluorescein leakage.

Haller JA, Dugel P, Weinberg DV, Chou C, Whitcup SM. · Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, USA. · Retina. · Pubmed #18827732 No free full text.

Abstract: PURPOSE: Evaluation of safety and performance of an applicator-inserted dexamethasone drug delivery system. METHODS: Patients with clinically observable macular edema were randomized to receive 700 microg dexamethasone drug delivery system via a pars plana incisional placement (n = 10) or a 22-gauge applicator insertion (n = 20). Outcome measures included assessment of procedure duration, the postinsertion wound, adverse events, intraocular pressure, and best-corrected visual acuity at baseline and days 1, 7, 14, 30, 60, 90, and 180. RESULTS: Both procedures were well tolerated and none of the patients in the applicator group required sutures to close the insertion wound. The overall incidence of ocular adverse events was less in the applicator group (13/19; 68.4%) than the incisional group (9/10; 90%), although the difference was not statistically significant in this pilot study. Vitreous hemorrhage occurred in two patients in the incisional group and none in the applicator group. Increases in intraocular pressure were less frequent in the applicator group (3/19; 15.8%) than the incisional group (3/10; 30%). No cases of endophthalmitis or retinal detachment occurred in either group. The percentage of patients achieving improvement in visual acuity of >/=15-letters at Day 90 was similar in both groups; 40% (8/20) in the applicator group and 30% (3/10) in the incisional group. CONCLUSION: The dexamethasone drug delivery system applicator system performed well, allowing safe, effective, and sutureless intravitreal placement of 700 microg dexamethasone drug delivery system.

Kuppermann BD, Blumenkranz MS, Haller JA, Williams GA, Weinberg DV, Chou C, Whitcup SM, Anonymous00222. · Department of Ophthalmology, University of California, Irvine, 118 Med Surge I, Irvine, CA 92697-4375, USA. · Arch Ophthalmol. · Pubmed #17353400 links to  free full text

Abstract: OBJECTIVE: To evaluate a dexamethasone intravitreous drug delivery system (DDS) in patients with persistent (> or =90 days despite treatment) macular edema. METHODS: This 6-month study randomized 315 patients with persistent macular edema with best-corrected visual acuity (BCVA) of 20/40 to 20/200 in the study eye to observation or a single treatment with dexamethasone DDS, 350 or 700 microg. MAIN OUTCOME MEASURES: Proportion of patients achieving a BCVA improvement of 10 or more letters or 15 or more letters, safety measures, change in fluorescein angiographic leakage, and central retinal thickness. RESULTS: At day 90 (primary end point), an improvement in BCVA of 10 letters or more was achieved by a greater proportion of patients treated with dexamethasone DDS, 700 microg (35%) or 350 microg (24%), than observed patients (13%; P<.001 vs 700-microg group; P = .04 vs 350-microg group); an improvement in BCVA of 15 letters or more was achieved in 18% of patients treated with dexamethasone DDS, 700 microg, vs 6% of observed patients (P = .006). Results were similar in patients with diabetic retinopathy, vein occlusion, or uveitis or Irvine-Gass syndrome. During 3 months of observation, 11% of treated patients and 2% of observed patients had intraocular pressure increases of 10 mm Hg or higher. CONCLUSION: In persistent macular edema, a single dexamethasone DDS treatment produced statistically significant BCVA improvements 90 days after treatment and was well tolerated for 180 days. Application to Clinical Practice Dexamethasone DDS, 700 microg, may have potential as a treatment for persistent macular edema.

Weinberg DV, Jampol LM. · No affiliation provided · Ophthalmology. · Pubmed #17157142 No free full text.

This publication has no abstract.

Holz ER, Linares L, Mieler WF, Weinberg DV. · Cullen Eye Institute, Baylor College of Medicine, Houston, TX 77030, USA. · Arch Ophthalmol. · Pubmed #14609931 No free full text.

This publication has no abstract.