Black Hills Regional Eye Institute

A post hoc study was conducted to compare visual and anatomic outcomes of vascularized serous pigment epithelial detachment (Group 1) with fibrovascular pigment epithelial detachment (Group 2) due to age-related macular degeneration treated with either 0.5 or 2.0 mg ranibizumab injections. A prospective, randomized trial was performed with the following regimens for 12 months: (1) 0.5 mg monthly, (2) 0.5 mg monthly for 4 months followed by pro re nata injections, (3) 2.0 mg monthly, and (4) 2.0 mg monthly for 4 months followed by pro re nata injections. Primary measure was best-corrected standardized vision. Secondary measures included central subfield, thickness surface area A2, greatest linear diameter, heights of pigment epithelial detachment and choroidal neovascularization (CNV), subretinal fluid, cystoid macular edema, and adverse events. For 36 eyes (8 in Group 1 and 28 in Group 2), follow-up time was 12 months. There were no differences in baseline features between groups except for pigment epithelial detachment A2 (Group 2 > Group 1). Two-way analysis of variance showed comparable improvements in anatomic and vision outcomes. Three-way analysis of variance also showed similar responses for both lesion subtypes with high-dose treatment. There was a trend toward greater pigment epithelial detachment resolution in Group 1 eyes. There were no differences in retinochoroidal angiomatous proliferation (Type-3 CNV) and cataracts between groups, although greater percentages of eyes in Group 1 developed retinal pigment epithelial tears (25% vs 10.7%). There were no differences in vision and anatomic outcomes between lesion subtypes, and similarly, more rapid responses to high-dose than conventional-dose ranibizumab occurred for eyes with both lesion subtypes. More retinal pigment epithelial tears may develop in eyes with vascularized serous pigment epithelial detachment.

The present study is the first randomized clinical trial designed to evaluate the intraocular pressure (IOP)-lowering effect of anecortave acetate (AA) administered at 3 doses (3, 15, or 30 mg) as an anterior juxtascleral depot (AJD) in patients experiencing elevated IOP due to corticosteroid therapy. This was a double-masked, randomized, placebo-controlled, multicenter, parallel group trial. Eligible patients had an IOP of at least 24 mmHg and an IOP increase of at least 10 mmHg relative to their IOP before treatment with steroids. A target IOP was established for each patient at baseline. Patients were randomized to 1 of the 4 treatment groups: vehicle, 3 mg AA, 15 mg AA, or 30 mg AA. All patients then received a 0.5 mL AJD of the assigned treatment. Patients returned for scheduled examination visits at weeks 1, 2, 4, 6, months 3, 4, 5, and 6. IOP was measured at each visit as well as best corrected visual acuity (logMAR), ocular motility, eyelid responsiveness, slit lamp examination, and assessment of any adverse events. In addition, at baseline and at exit, a dilated fundus examination was carried out and the lens was examined using LOCS II criteria. Seventy patients were randomized to treatment. At week 4, eyes in the vehicle group showed a 3.4 mmHg (9.1%) decrease from baseline. Reductions for the 3 mg AA (3.1 mmHg, 10.7%) and the 30 mg AA groups (5.4 mmHg, 16.6%) were not significantly different than for vehicle control. However, IOP for the 15 mg AA group at week 4 was reduced 11.5 mmHg (31.3%) from baseline, which was statistically significant (P=0.0487). The mean time to treatment failure was 32.2, 38.9, 56.3, and 32.6 days for the vehicle, 3 mg AA, 15 mg AA, and 30 mg AA groups, respectively. Adverse events were assessed at each post-treatment visit. There were no serious adverse events that were determined to be related to the test article or its administration. AA can be of benefit to some patients requiring treatment with corticosteroids, but suffering from the side effect of elevated IOP.