Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105027
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2005-03-03
Brief Title:
The Standard Care vs COrticosteroid for REtinal Vein Occlusion SCORE Study
Sponsor:
The Emmes Company LLC
Organization:
The Emmes Company LLC
Study Overview
Official Title:
The Standard Care vs COrticosteroid for REtinal Vein Occlusion SCORE Study Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injections of Triamcinolone Acetonide With Standard Care to Treat Macular Edema
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCORE
Brief Summary:
The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injections 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:
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 injections 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 111 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
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 injections 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 111 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U10EY014352 | NIH | None | httpsreporternihgovquickSearch5U10EY014352 |
| 5U10EY014351-05 | NIH | None | None |
| 5U10EY014404 | NIH | None | None |