The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study

Study Overview
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Brief Summary
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The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).

Detailed Description
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Macular edema is a major cause of vision loss in patients with CRVO and BRVO. Both CRVO and BRVO are common retinal problems and are caused by a blockage in one of the large retinal veins (central retinal vein occlusion - CRVO) or smaller retinal veins (branch retinal vein occlusion - BRVO). Currently, there is no effective treatment for macular edema associated with CRVO and standard care treatment is observation. Grid laser photocoagulation may be effective for some patients for macular edema associated with BRVO, but many patients derive limited benefit from this treatment. Therefore, the development of new treatment modalities for macular edema caused by these two conditions is an important research goal. Over the last several years, many patients with macular edema from CRVO and BRVO have been treated with an injection of a type of steroid called triamcinolone directly into the eye. This type of injection is called an intravitreal injection. The triamcinolone preparation commonly injected into the eye is Kenalog and is FDA-approved only for use in muscles and joints. The SCORE Study will use a formulation of triamcinolone made specifically for the eye. The SCORE Study is a multicenter, randomized, Phase III trial to compare the effectiveness and safety of standard care versus triamcinolone 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 (similar to a flip of a coin) in a 1:1:1 ratio to one of three groups: standard care, intravitreal triamcinolone 4 mg, or intravitreal triamcinolone 1 mg. After randomization, participants will be examined every 4 months through 3 years to collect ophthalmic information, including visual acuity, intraocular pressure, optical coherence tomography, and fundus photography . Fluorescein angiography will be performed at 4, 12 and 24 months. Repeat intravitreal injections of triamcinolone and repeat laser treatment will be provided as clinically indicated based on protocol-specific guidelines. The primary outcome is improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit. Secondary outcomes include changes from baseline in best-corrected ETDRS visual acuity score, changes in retinal thickness as assessed by stereoscopic color fundus photography and optical coherence tomography, and adverse ocular outcomes.

Official Title
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The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide With Standard Care to Treat Macular Edema

Conditions
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Macular Edema, Cystoid, Retinal Vein Occlusion

Intervention / Treatment
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* Other: Standard Care
* Drug: intravitreal triamcinolone injection
* Drug: intravitreal triamcinolone injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). Individuals, 18 years of age or older, willing to provide consent may be eligible for the SCORE Study. Exclusion Criteria: refer to SCORE Study website at https://web.emmes.com/study/score/ for listing.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CRVO Observation<br> | Other: Standard Care<br>* CRVO: observation; BRVO: standard care<br>|
| Active Comparator: CRVO 1 mg dose triamcinolone acetonide<br> | Drug: intravitreal triamcinolone injection<br>* 1 mg dose<br>|
| Active Comparator: CRVO 4 mg dose triamcinolone acetonide<br> | Drug: intravitreal triamcinolone injection<br>* 4 mg<br>|
| Active Comparator: BRVO standard care<br> | Other: Standard Care<br>* CRVO: observation; BRVO: standard care<br>|
| Active Comparator: BRVO 1 mg dose triamcinolone acetonide<br> | Drug: intravitreal triamcinolone injection<br>* 1 mg dose<br>|
| Active Comparator: BRVO 4 mg dose triamcinolone acetonide<br> | Drug: intravitreal triamcinolone injection<br>* 4 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit | Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart. | Change from baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Best-corrected ETDRS Visual Acuity Score |  | 12 months | 
| Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography |  | 12 months | 
| Adverse Ocular Outcomes |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular edema, central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO)