Citation: Ip MS, Scott IU, VanVeldhuisen PC, et al. A randomized trial comparing the efficacy and safety of intravitreal triamcinolone with observation to treat vision loss associated with macular edema secondary to central retinal vein occlusion: the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study report 5. Arch Ophthalmol. 2009;127(9):1101-1114.
- 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-CRVO trial compared preservative-free intravitreal triamcinolone (Trivaris, Allergan) to observation, which was the standard care for CRVO at the time the SCORE study was planned in 2003.
- Participants were randomized to no therapy or 1-mg or 4-mg of intravitreal triamcinolone every 4 months for 1 year.
- Intravitreal triamcinolone in both 1-mg and 4-mg doses had better visual outcomes, with an average of 2 injections over 12 months, compared to observation.
- The 1-mg triamcinolone is the preferred dose due to superior safety profile, as the 4-mg showed higher rates of cataract formation and elevated intraocular pressure (IOP).
To determine whether intravitreal triamcinolone at doses of 1-mg or 4-mg produces greater visual benefit, with an acceptable safety profile, versus observation alone for the treatment of macular edema associated with CRVO.
Multicenter, prospective, randomized clinical trial
- Inclusion criteria: Patients with macular edema associated with CRVO, 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 observation, intravitreal triamcinolone 1mg, or intravitreal triamcinolone 4 mg.
- Participants and physicians were masked to the intravitreal triamcinolone dose (1 mg vs 4 mg) but were not masked to the treatment of observation vs intravitreal triamcinolone.
- Participants assigned to the intravitreal triamcinolone groups were treated at baseline and were retreated at 4-month intervals for 1 year at provider discretion. 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
- 271 patients diagnosed with macular edema secondary to CRVO
- Participants were followed at 4-month intervals through month 12, then annually through month 36
- At month 12, the average number of injections was similar between triamcinolone groups, with 2.2 in the 1-mg triamcinolone group and 2.0 in the 4-mg triamcinolone group.
- At the end of 12 months, visual gains of 3 or more lines (15 or more letters) were seen in 26.5% of 1-mg group and 25.6% of 4-mg group, compared to 6.8% in the observation group.
- Visual acuity gains were sustained at 2 years, although there was a mild attenuation of the effect of triamcinolone. Two-year data is limited due to decreased follow-up (56% at 2 years compared to 88% 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.
- Rates of increased IOP (measured by need to start IOP lowering drops) were highest in the 4-mg triamcinolone group at 35%, compared to 20% in the 1-mg group and 8% in observation.
- Rates of cataract development were highest in the 4-mg triamcinolone group at 33%, compared to 26% in the 1-mg group and 18% in observation.
- In this randomized clinical trial, intravitreal triamcinolone was shown to be superior to observation for the treatment of vision loss from macular edema in CRVO. The 1-mg dose has a superior safety profile to the 4-mg dose.