Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101764
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-01-12
Brief Title:
Intravitreal v Sub-tenon Injections of Triamcinolone Acetonide for Macular Edema in Retinal Disorders
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of Intravitreal Injections Versus Anterior Sub-Tenon Injections of Triamcinolone Acetonide Formulation for Macular Edema in Retinal Disorders
Status:
COMPLETED
Status Verified Date:
2008-05-20
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:
The use of intravitreal injections of corticosteroid triamcinolone acetonide appears to be a promising treatment for a variety of ocular diseases associated with inflammation To date the only drug available Kenalog-40 Injection produced by Bristol Myers Squibb has not been formulated for intraocular use
The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide TAC-PF at two dosage levels 4 mg and 8 mg compared to anterior sub-tenon injections of TAC-PF at 20 mg
The study will be a masked randomized Phase I study that will enroll 120 participants with one of the following diseases age-related macular degeneration AMD diabetic macular edema DME central retinal vein occlusion CRVO branch retinal vein occlusion BRVO or any other retinal disease with associated macular edema At least 21 participants will be enrolled in the four designated disease strata AMD DME CRVO and BRVO The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease Within each disease strata at least seven participants will be randomized to each dosing group The participants will be randomly assigned to one of the three treatment groups
The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up including cataract formation development of glaucoma and any adverse event preventing retreatment The secondary outcomes will be an improvement in best-corrected visual acuity BCVA EVA and decreases in retinal thickening and area of leakage from baseline to year 1
The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide TAC-PF at two dosage levels 4 mg and 8 mg compared to anterior sub-tenon injections of TAC-PF at 20 mg
The study will be a masked randomized Phase I study that will enroll 120 participants with one of the following diseases age-related macular degeneration AMD diabetic macular edema DME central retinal vein occlusion CRVO branch retinal vein occlusion BRVO or any other retinal disease with associated macular edema At least 21 participants will be enrolled in the four designated disease strata AMD DME CRVO and BRVO The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease Within each disease strata at least seven participants will be randomized to each dosing group The participants will be randomly assigned to one of the three treatment groups
The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up including cataract formation development of glaucoma and any adverse event preventing retreatment The secondary outcomes will be an improvement in best-corrected visual acuity BCVA EVA and decreases in retinal thickening and area of leakage from baseline to year 1
Detailed Description:
The use of intravitreal injections of corticosteroid triamcinolone acetonide appears to be a promising treatment for a variety of ocular diseases associated with inflammation To date the only drug available Kenalog-40 Injection produced by Bristol Myers Squibb has not been formulated for intraocular use
The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide TAC-PF at two dosage levels 4 mg and 8 mg compared to anterior sub-tenon injections of TAC-PF at 20 mg
The study will be a masked randomized Phase I study that will enroll 120 participants with one of the following diseases age-related macular degeneration AMD diabetic macular edema DME central retinal vein occlusion CRVO branch retinal vein occlusion BRVO or any other retinal disease with associated macular edema At least 21 participants will be enrolled in the four designated disease strata AMD DME CRVO and BRVO The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease Within each disease strata at least seven participants will be randomized to each dosing group The participants will be randomly assigned to one of the three treatment groups Depending on a participants response injections may be repeated at 3-month intervals Participants will be followed until the last enrolled participant completes 3 years of follow-up
The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up including cataract formation development of glaucoma and any adverse event preventing retreatment The secondary outcomes will be an improvement in best-corrected visual acuity BCVA and decreases in retinal thickening and area of leakage from baseline to year 1
The purpose of this study is to evaluate the long-term safety and potential efficacy of novel intravitreal injections of a preservative-free formulation of triamcinolone acetonide TAC-PF at two dosage levels 4 mg and 8 mg compared to anterior sub-tenon injections of TAC-PF at 20 mg
The study will be a masked randomized Phase I study that will enroll 120 participants with one of the following diseases age-related macular degeneration AMD diabetic macular edema DME central retinal vein occlusion CRVO branch retinal vein occlusion BRVO or any other retinal disease with associated macular edema At least 21 participants will be enrolled in the four designated disease strata AMD DME CRVO and BRVO The remaining 36 participants may have one of these diseases or may be enrolled with another retinal disease Within each disease strata at least seven participants will be randomized to each dosing group The participants will be randomly assigned to one of the three treatment groups Depending on a participants response injections may be repeated at 3-month intervals Participants will be followed until the last enrolled participant completes 3 years of follow-up
The primary outcome will be an assessment of post-injection intraocular toxicity-related events during the 3-year follow-up including cataract formation development of glaucoma and any adverse event preventing retreatment The secondary outcomes will be an improvement in best-corrected visual acuity BCVA and decreases in retinal thickening and area of leakage from baseline to year 1
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 |
|---|---|---|---|
| 05-EI-0071 | None | None | None |