Clinical Studies:
SCORE-BRVO
Citation: Scott IU, Ip MS, VanVeldhuisen PC, et al. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with standard care to treat vision loss associated with macular Edema secondary to branch retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 6. Arch Ophthalmol. 2009;127(9):1115-1128.
Key Points
- Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study, sponsored by the National Eye Institute, was designed to compare 1-mg and 4-mg doses of intravitreal triamcinolone with standard care for the treatment of vision loss associated with macular edema from perfused central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
- SCORE-BRVO trial compared 1-year outcomes of preservative-free intravitreal triamcinolone (Trivaris, Allergan) to grid photocoagulation, which was the standard care for BRVO at the time the SCORE study was planned in 2003.
- Participants randomized to grid photocoagulation received an average of 1.5 treatments over 1 year, and participants in the 1-mg and 4-mg intravitreal triamcinolone group had an average of 2 injections.
- There was no difference in visual acuity at 12 months among all three groups. The rates of elevated IOP and cataract were similar for standard care and 1-mg groups, but higher in the 4-mg groups.
- SCORE-BRVO recommended that laser remain the standard of care for the treatment of BRVO.
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Objective
To determine whether intravitreal triamcinolone at doses of 1-mg or 4-mg produces greater visual benefit, with an acceptable safety profile, versus grid photocoagulation for the treatment of macular edema associated with BRVO.
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STUDY DESIGN
Multicenter, prospective, randomized clinical trial
STUDY SUBJECTS
- Inclusion criteria: Patients with macular edema associated with BRVO (included hemiretinal vein occlusion), with best corrected EDTRS visual acuity ≤ 73 (approximate Snellen equivalent, 20/40 or worse) and ≥ 19 (20/400 or better)
- Exclusion criteria: Prior treatment with intravitreal/peribulbar steroids, visually significant cataract or ocular condition, recent history of any photocoagulation, recent ocular surgery or procedure, ocular hypertension or glaucoma, aphakia
RANDOMIZATION SCHEME AND INTERVENTIONS
- Subjects who met the inclusion criteria were randomly assigned to standard care, intravitreal triamcinolone 1mg, or intravitreal triamcinolone 4 mg.
- Standard care was defined as grid photocoagulation if there was no dense macular hemorrhage. If hemorrhage present, patients were treated with observation at 4-month intervals until the macular hemorrhage cleared sufficiently for laser.
- Participants and physicians were masked to the intravitreal triamcinolone dose (1 mg vs 4 mg) but were not masked to the treatment of grid photocoagulation vs intravitreal triamcinolone.
- Participants were treated at baseline and were retreated at 4-month intervals for 1 year at provider discretion in all three groups. Reasons to defer retreatment included treatment deemed successful, contraindications encountered, or further treatment deemed likely futile.
MAIN OUTCOME MEASURE:
- Gain of ≥15 letters from baseline to month 12
RESULTS
Study population:
- 411 patients diagnosed with macular edema secondary to BRVO
Follow-up time:
- Participants were followed at 4-month intervals through month 12, then annually through month 36
Treatment:
- At month 12, the average number of injections was similar between triamcinolone groups, with 2.2 in the 1-mg triamcinolone group and 2.1 in the 4-mg triamcinolone group. The average number of grid photocoagulation treatments was 1.5, with 1.8 treatments in patients without dense macular hemorrhage and 0.7 treatments in patients with hemorrhage.
Visual acuity end-points
- Mean visual acuity: -8.6 letters from entry into ANCHOR/MARINA; - 19.8 letters from peak vision upon completion of 24 months of monthly ranibizumab treatment in ANCHOR/MARINA; -6.9 letters from 24-month visit in HORIZON study
- Compared to entry in ANCHOR/MARINA, 66% stable or improved (12% with ≥ 15 letter gain; 54% stable), 34% with ≥ 15 letter loss
- Compared to time of exit from ANCHOR/MARINA, 15% with stable or improved vision, 85% worse
- Compared to the month 24 HORIZON measurement, 32% had stable or improved vision, 68% worse
Treatment
- Mean 6.8 injections over 3.4 years (2 injections/year) in the years after exiting HORIZON
- 41% of eyes received 0 injections
Outcomes:
- At the end of 12 months, visual gains of 3 or more lines (15 or more letters) was similar in all groups: 28.9% in standard care, 25.6% in 1-mg group, and 27.2% in 4-mg group
- After month 12 through month 36, the mean improvement from baseline visual acuity was greatest in the grid photocoagulation group compared to the two injection groups. Three-year data is limited due to decreased follow-up (31% at 3 years compared to 89% at 1 year)
- All three groups showed decreased central retinal thickness on OCT, which was greatest in the triamcinolone 4-mg group at 4 months. However, there was no difference among all three groups at 12 months.
Safety:
- Rates of increased IOP (measured by need to start IOP lowering drops) were highest in the 4-mg triamcinolone group at 41%, compared to 7% in the 1-mg group and 2% in observation.
- Rates of cataract development were highest in the 4-mg triamcinolone group at 35%, compared to 25% in the 1-mg group and 13% in observation.
CONCLUSIONS
- In this randomized clinical trial, there was no difference in visual acuity outcomes for the grid photocoagulation group compared with the triamcinolone groups.
- Given the risk of adverse events associated with intravitreal triamcinolone, especially in the 4-mg dose, grid photocoagulation should remain the standard of care for macular edema secondary to BRVO.