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Corticosteroid
BRVO 1 mg dose triamcinolone acetonide for Central Retinal Vein Occlusion (SCORE Trial)
Phase 3
Waitlist Available
Research Sponsored by The Emmes Company, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial
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).
Eligible Conditions
- Central Retinal Vein Occlusion
- Cystoid macular edema
- Retinal Vein Occlusion
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
6Treatment groups
Active Control
Group I: BRVO 1 mg dose triamcinolone acetonideActive Control1 Intervention
Group II: BRVO 4 mg dose triamcinolone acetonideActive Control1 Intervention
Group III: CRVO 1 mg dose triamcinolone acetonideActive Control1 Intervention
Group IV: CRVO ObservationActive Control1 Intervention
Group V: CRVO 4 mg dose triamcinolone acetonideActive Control1 Intervention
Group VI: BRVO standard careActive Control1 Intervention
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Who is running the clinical trial?
The Emmes Company, LLCLead Sponsor
147 Previous Clinical Trials
1,051,456 Total Patients Enrolled
National Eye Institute (NEI)NIH
555 Previous Clinical Trials
1,406,710 Total Patients Enrolled
AllerganIndustry Sponsor
781 Previous Clinical Trials
275,972 Total Patients Enrolled
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