Phase 3
N=682
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study
Macular Edema, Cystoid · Retinal Vein Occlusion
Bottom Line
View on ClinicalTrials.gov: NCT00105027 ↗Enrolled (actual)
682
Serious AEs
43.6%
Results posted
Jan 2011
Primary outcome: Primary: 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 — 5; 22; 21; 35 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Standard Care (Other); intravitreal triamcinolone injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Emmes Company, LLC
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
5; 22; 21; 35; 31; 34 | — |
| SECONDARY Changes From Baseline in Best-corrected ETDRS Visual Acuity Score |
-12.1; -1.2; -1.2; 4.2; 5.7; 4.0 | — |
| SECONDARY Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography |
-277; -196; -261; -224; -149; -170 | — |
| SECONDARY Adverse Ocular Outcomes |
7; 18; 32; 3; 11; 57 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00105027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.