Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 1:21 PM
Study NCT ID:
NCT00106132
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2005-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steroid Injections vs. Standard Treatment for Macular Edema Due to Retinal Blood Vessel Blockage
Sponsor:
National Eye Institute (NEI)
Organization:
Study Overview
Official Title:
The Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) Study
Status:
COMPLETED
Status Verified Date:
2005-11
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:
None
Brief Summary:
This study will compare the safety and effectiveness of two treatments-injections of triamcinolone acetonide into the eye vs. standard laser therapy-for macular edema (swelling in the center of the retina) that is caused by blockage in a retinal blood vessel. Edema caused by blockage in a large vessel is called central retinal vein occlusion (CRVO). Edema caused by blockage in a smaller vein is called branch retinal vein occlusion (BRVO). Triamcinolone acetonide is a steroid drug that reduces swelling; the Food and Drug Administration has approved it for injection into joints and muscles to treat inflammatory conditions.
Patients 18 years of age and older with macular edema due to CRVO or BRVO of between 3 and 18 months' duration may be eligible for this study. Candidates are screened with a medical history, blood pressure measurement, and urine pregnancy test for women who can become pregnant. Screening also includes the following procedures:
* Eye examination to assess visual acuity and eye pressure, and to examine the cornea, lens, and retina. The pupils are dilated with drops for this examination.
* Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality.
* Optical coherence tomography to measure retinal thickness. The eye is examined with a machine that produces cross-sectional pictures of the retina. The patient is seated in front of a machine and looks at a pattern of flashing and rotating red and green lights, first with one eye and then with the other.
* Fundus photography to help evaluate the status of the retina and changes that may occur in the future. Photographs of the retina are taken using a camera that flashes a bright light into the eye.
Participants are randomly assigned to receive triamcinolone injections or standard treatment. Triamcinolone is given in either a 1-mg or 4-mg dose. Standard treatment for CRVO and for BRVO with excessive blood in the retina is observation. Standard treatment for BRVO without excessive blood is laser therapy. Patients with BRVO who do not qualify for laser therapy when they enter the study may have it later if blood clears enough to permit treatment. The procedures for triamcinolone injections and laser therapy are as follows:
* Triamcinolone acetonide: The eye is numbed with anesthetic drops and the study drug is injected into the vitreous, the jelly-like substance located between the back of the lens and the retina. Patients apply antibiotic drops at home for 3 days following the procedure.
* Laser treatment: The eye is numbed with anesthetic drops and a special contact lens is placed on the eye during the laser beam application.
All patients are followed every 4 months for 3 years. Additional visits may be scheduled if needed. Patients who receive triamcinolone injections are also examined within 1 week of each injection and 1 month after each injection. At the 4-month visits patients undergo repeat eye examination and fundus photography. Optical coherence tomography is done at some visits, and fluorescein angiography is repeated at months 4, 12 and 24. Blood pressure is measured at months 12, 24 and 36. Patients may be retreated with triamcinolone injections or laser therapy as often as every 4 months, depending on their response to treatment.
Patients 18 years of age and older with macular edema due to CRVO or BRVO of between 3 and 18 months' duration may be eligible for this study. Candidates are screened with a medical history, blood pressure measurement, and urine pregnancy test for women who can become pregnant. Screening also includes the following procedures:
* Eye examination to assess visual acuity and eye pressure, and to examine the cornea, lens, and retina. The pupils are dilated with drops for this examination.
* Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality.
* Optical coherence tomography to measure retinal thickness. The eye is examined with a machine that produces cross-sectional pictures of the retina. The patient is seated in front of a machine and looks at a pattern of flashing and rotating red and green lights, first with one eye and then with the other.
* Fundus photography to help evaluate the status of the retina and changes that may occur in the future. Photographs of the retina are taken using a camera that flashes a bright light into the eye.
Participants are randomly assigned to receive triamcinolone injections or standard treatment. Triamcinolone is given in either a 1-mg or 4-mg dose. Standard treatment for CRVO and for BRVO with excessive blood in the retina is observation. Standard treatment for BRVO without excessive blood is laser therapy. Patients with BRVO who do not qualify for laser therapy when they enter the study may have it later if blood clears enough to permit treatment. The procedures for triamcinolone injections and laser therapy are as follows:
* Triamcinolone acetonide: The eye is numbed with anesthetic drops and the study drug is injected into the vitreous, the jelly-like substance located between the back of the lens and the retina. Patients apply antibiotic drops at home for 3 days following the procedure.
* Laser treatment: The eye is numbed with anesthetic drops and a special contact lens is placed on the eye during the laser beam application.
All patients are followed every 4 months for 3 years. Additional visits may be scheduled if needed. Patients who receive triamcinolone injections are also examined within 1 week of each injection and 1 month after each injection. At the 4-month visits patients undergo repeat eye examination and fundus photography. Optical coherence tomography is done at some visits, and fluorescein angiography is repeated at months 4, 12 and 24. Blood pressure is measured at months 12, 24 and 36. Patients may be retreated with triamcinolone injections or laser therapy as often as every 4 months, depending on their response to treatment.
Detailed Description:
Macular edema is a major cause of vision loss in patients with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). Currently, there is no effective treatment for macular edema associated with CRVO. For macular edema associated with BRVO, grid laser photocoagulation may be an effective treatment, but many patients derive limited benefit from this treatment. Therefore, the development of new treatment modalities to treat macular edema caused by these two conditions is an important research goal. The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study will compare the efficacy and safety of standard care with intravitreal injection(s) of triamcinolone acetonide to treat macular edema associated with CRVO and BRVO.
The SCORE Study is designed as a multicenter, randomized, Phase III trial to compare the efficacy and safety of standard care versus triamcinolone acetonide 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 in a 1:1:1 ratio to one of three groups: standard care, intravitreal triamcinolone 4 mg, or intravitreal triamcinolone 1 mg. For CRVO participants, standard care consists of observation of the macular edema. For BRVO participants, standard care consists of immediate grid laser photocoagulation for study eyes without a dense macular hemorrhage. For study eyes of BRVO participants with a dense macular hemorrhage, standard care is observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For all three groups, neovascular complications will be treated as necessary. Repeat treatments will be provided as clinically indicated based on protocol-specific guidelines. Participants will be followed for 3 years after randomization. The primary efficacy outcome of this study is improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit. Secondary efficacy outcomes include change between baseline and each efficacy outcome assessment visit in best-corrected ETDRS visual acuity score, change in retinal thickness at the center of the macula and change in area of retinal thickening as assessed by stereoscopic color fundus photography, and change in retinal thickness and calculated retinal thickening as assessed by optical coherence tomography. Safety outcomes include injection-related adverse events such as infectious endophthalmitis, non-infectious endophthalmitis, retinal detachment, and vitreous hemorrhage and steroid-related adverse events, which include cataract and elevated intraocular pressure.
The SCORE Study is designed as a multicenter, randomized, Phase III trial to compare the efficacy and safety of standard care versus triamcinolone acetonide 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 in a 1:1:1 ratio to one of three groups: standard care, intravitreal triamcinolone 4 mg, or intravitreal triamcinolone 1 mg. For CRVO participants, standard care consists of observation of the macular edema. For BRVO participants, standard care consists of immediate grid laser photocoagulation for study eyes without a dense macular hemorrhage. For study eyes of BRVO participants with a dense macular hemorrhage, standard care is observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For all three groups, neovascular complications will be treated as necessary. Repeat treatments will be provided as clinically indicated based on protocol-specific guidelines. Participants will be followed for 3 years after randomization. The primary efficacy outcome of this study is improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit. Secondary efficacy outcomes include change between baseline and each efficacy outcome assessment visit in best-corrected ETDRS visual acuity score, change in retinal thickness at the center of the macula and change in area of retinal thickening as assessed by stereoscopic color fundus photography, and change in retinal thickness and calculated retinal thickening as assessed by optical coherence tomography. Safety outcomes include injection-related adverse events such as infectious endophthalmitis, non-infectious endophthalmitis, retinal detachment, and vitreous hemorrhage and steroid-related adverse events, which include cataract and elevated intraocular pressure.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 05-EI-0101 | None | None | View |