Injecting the eye with the corticosteroid triamcinolone appears effective in improving the vision of some patients with retinal vein occlusion, an important cause of vision loss that results from blockages in the blood vessels in the retina, according to two reports in the September issue of Archives of Ophthalmology, one of the JAMA/Archives journals. A 1-milligram dose of triamcinolone may be a treatment option for certain patients with blockages in the main portion of the retinal vein, whereas existing laser therapies appear superior for those with blockages in smaller branches of the vein.
Retinal vein occlusion is an important cause of vision loss in the United States and worldwide, according to background information in the articles. The condition frequently occurs in individuals with diabetes and leads to macular edema, or fluid buildup in the retina. Grid photocoagulation, or a laser treatment of the retina, has shown a benefit in improving the vision of patients with branch retinal vein occlusion (blockages in smaller branches of the retinal vein). However, there is presently no proven, effective therapy for vision loss associated with macular edema after central retinal vein occlusion (blockage in the main portion of the retinal vein, at the optic nerve).
In one paper, the SCORE (Standard Care vs. Corticosteroid for Retinal Vein Occlusion) Study Research Group reports the results of a randomized clinical trial involving 271 participants with macular edema from central retinal vein occlusion. Of these, 92 were assigned to receive 1 milligram of intravitreal (injected into the eye) triamcinolone, 91 received a 4-milligram dose and 88 were assigned to an observation group that did not receive treatment.
Participants were evaluated every four months for 12 months, and those in the triamcinolone group received additional injections at each follow-up visit unless there was a specific reason not to re-treat them (for instance, adverse events or apparent success of the treatment). Additional follow-up data were collected annually through 36 months, although complete 24- and 36-month outcome assessments were not available for analysis.
After one year, vision improved significantly in 7 percent of those in the observation group, 27 percent of those in the 1-milligram triamcinolone group and 26 percent of those in the 4-milligram triamcinolone group. The odds of reaching a predetermined level of visual improvement were five times greater among individuals receiving either dose of triamcinolone than those not receiving treatment.
Cataracts and elevated intraocular pressure (pressure within the eyeball), potential adverse events associated with corticosteroid treatment, were similar for the observation and 1-milligram group but higher for the 4-milligram group. "The superior safety profile of the 1-milligram dose compared with the 4-milligram dose, particularly with respect to glaucoma and cataract, renders it the preferred dose," the authors write.
Based on the results, "intravitreal triamcinolone in a 1-milligram dose and following the retreatment criteria used in this study should be considered for up to one year, and possibly two years, in patients with vision loss associated with macular edema secondary to central retinal vein occlusion who have characteristics similar to the participants studied in this trial," they conclude.
In a second study, the same research group compared the safety and efficacy of triamcinolone with standard care (grid photocoagulation in eyes without hemorrhage, or deferring photocoagulation until hemorrhage clears) for 411 patients with macular edema from branch retinal vein occlusion. A group of 137 was assigned to receive standard care, 136 to receive a 1-milligram dose of intravitreal triamcinolone and 138 to receive a 4-milligram dose. Similar to the central retinal occlusion trial, participants were evaluated and re-treated as indicated every four months.
After one year, 29 percent of participants in the standard care group, 26 percent in the 1-milligram triamcinolone group and 27 percent in the 4-milligram group experienced improved vision.
"The rates of adverse events with respect to cataract surgery and elevated intraocular pressure were similar between the standard care and 1-milligram groups, but the potential for added risks of procedure-related complications in the 1-milligram group (as exemplified by the one case of endophthalmitis [inflammation inside the eye] reported in the 4-milligram group) suggests a superior safety profile for the standard care group," the authors write. Adverse event rates were higher in the 4-milligram group.
"Thus, current study results (up to 12 months and possibly up to 36 months) support grid photocoagulation as the continued standard of care for patients with decreased visual acuity associated with macular edema secondary to branch retinal vein occlusion who have similar characteristics to the cohort in this clinical trial," the authors conclude. "The results of this trial also support the idea that grid photocoagulation, as applied in the current study, should be the benchmark against which other treatments for vision loss associated with macular edema secondary to branch retinal vein occlusion are compared in clinical trials."
(Arch Ophthalmol. 2009;127[9]:1101-1114, 1115-1128. Available pre-embargo to the media at www.jamamedia.org.)
Editor's Note: These studies were supported by grants from the National Eye Institute and in part by Allergan Inc. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Editorial: Studies Will Influence Treatment of Common Eye Disease
"Retinal venous occlusive disease, including branch retinal vein occlusion and central retinal vein occlusion, is the second most common cause of severe vision loss in the United States," writes Rajendra S. Apte, M.D., Ph.D., of Washington University School of Medicine, St. Louis, in an accompanying editorial.
The results of the SCORE studies "provide valuable evidence regarding the role of laser photocoagulation and intravitreal triamcinolone in the management of macular edema associated with venous occlusive disease," Dr. Apte concludes. "These studies also provide important ocular safety information that confirms the previously reported associations of intraocular triamcinolone with intraocular pressure elevation and cataract development and progression. These well-designed studies will influence future research, treatment paradigms and clinical practice patterns for years to come."
Source: JAMA and Archives Journals