Steroid Injections vs. Standard Treatment for Macular Edema Due to Retinal Blood Vessel Blockage

Macular edema is a major cause of vision loss in patients with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). Currently, there is no effective treatment for macular edema associated with CRVO. For macular edema associated with BRVO, grid laser photocoagulation may be an effective treatment, but many patients derive limited benefit from this treatment. Therefore, the development of new treatment modalities to treat macular edema caused by these two conditions is an important research goal. The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study will compare the efficacy and safety of standard care with intravitreal injection(s) of triamcinolone acetonide to treat macular edema associated with CRVO and BRVO. The SCORE Study is designed as a multicenter, randomized, Phase III trial to compare the efficacy and safety of standard care versus triamcinolone acetonide injection(s) for the treatment of macular edema associated with CRVO and BRVO. In each of the two disease areas, 630 participants will be randomized in a 1:1:1 ratio to one of three groups: standard care, intravitreal triamcinolone 4 mg, or intravitreal triamcinolone 1 mg. For CRVO participants, standard care consists of observation of the macular edema. For BRVO participants, standard care consists of immediate grid laser photocoagulation for study eyes without a dense macular hemorrhage. For study eyes of BRVO participants with a dense macular hemorrhage, standard care is observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For all three groups, neovascular complications will be treated as necessary. Repeat treatments will be provided as clinically indicated based on protocol-specific guidelines. Participants will be followed for 3 years after randomization. The primary efficacy outcome of this study is improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit. Secondary efficacy outcomes include change between baseline and each efficacy outcome assessment visit in best-corrected ETDRS visual acuity score, change in retinal thickness at the center of the macula and change in area of retinal thickening as assessed by stereoscopic color fundus photography, and change in retinal thickness and calculated retinal thickening as assessed by optical coherence tomography. Safety outcomes include injection-related adverse events such as infectious endophthalmitis, non-infectious endophthalmitis, retinal detachment, and vitreous hemorrhage and steroid-related adverse events, which include cataract and elevated intraocular pressure.