Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Eye Institute (NEI) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00071227 |
This study will evaluate the safety and effectiveness of a new formulation of triamcinolone acetonide for the treatment of retinal blood vessel disorders. Triamcinolone is a steroid drug that decreases inflammation and scarring and is routinely used to treat eye inflammation or swelling. The commercially available form of this drug is associated with potentially harmful side effects thought to be due to preservatives in the preparation.
This study will use a formulation that does not contain these potentially harmful preservatives. Preliminary findings from other studies suggest that injection of steroids in the eye can reduce retinal thickening and improve vision. However, they may also cause mild discomfort and lead to vision-threatening conditions. The effects of the drug on the conditions under study in this protocol are not known.
Patients with the following conditions involving disorders of retinal blood vessels may be eligible for this study:
Participants undergo the following tests and procedures:
An antibiotic eye ointment is used for 2 days following treatment.
Patients return to the clinic for follow-up visits 1, 4, and 7 days, and 1 month after the first treatment.
Patients whose condition does not improve after 3 months do not receive any more injections, but return for eye examinations at least once a year for 3 years. Patients whose condition improves with treatment return for follow-up visits 6 and 9 months after the first injection and then every 6 months for 2 more years. At each visit, a determination is made whether another injection is needed. After each repeat injection, patients return for follow-up visits at 1, 4, and 7 days after the injection.
Condition | Intervention | Phase |
---|---|---|
Macular Degeneration Retinal Vein Occlusion |
Drug: Triamcinolone Acetonide (TAC-PF) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Study of Intravitreal Injection of Triamcinolone Acetonide Formulation for Retinal Vascular Disorders |
Estimated Enrollment: | 16 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | August 2007 |
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. This formulation when used intraocularly has been associated with cases of non-bacterial endophthalmitis, which is thought to be due to the presence of benzyl alcohol and/or polysorbate 80. Both are suspected irritants.
The purpose of this study is to evaluate the safety of a novel preservative-free formulation of triamcinolone acetonide (TAC-PF) at four dosage levels.
The study will be an open-label, single-masked, randomized Phase I study that will investigate the safety and potential efficacy of the new formulation of TAC-PF. Sixteen participants with retinal vascular disease will be randomly assigned to receive via intravitreal injection at one of 4 dose levels (1 mg, 4 mg, 8 mg, or 16 mg) of TAC-PF. Depending on a participant's response, injections may be repeated at up to 3 month intervals.
Participants will be followed for 3 years.
The primary outcome will be an assessment of post-injection intraocular toxicity related events including increased inflammation, increased intraocular pressure, significant decreases in BCVA, cataract formation, retinal detachment, and intraocular hemorrhage. The secondary outcomes will be an improvement of 15 letters in best-corrected visual acuity (BCVA, ETDRS) from baseline to year 3, and decreases in retinal thickening and area of leakage.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
All participants must:
INCLUSION CRITERIA - DISEASE-SPECIFIC:
Participants with neovascular AMD:
Have the presence of choroidal neovascularization under the fovea determined by the investigator and defined as any one of the following fluorescein angiographic (FA) features:
Irregular elevation of the retinal pigment epithelium that does not exhibit discrete or bright hyperfluorescence in the early transit phase of the angiogram. Stippled hyperfluorescence may be present.
Late frames may show persistent fluorescein staining or leakage within a sensory retinal detachment overlying this area.
Participants with central retinal vein occlusion:
Participants with diabetic macular edema:
EXCLUSION CRITERIA - GENERAL:
All participants must not:
Be currently using or be likely to need systemic or ocular medications known to be toxic to the lens, retina, or optic nerve, such as:
EXCLUSION CRITERIA - DISEASE SPECIFIC:
Participants with Neovascular AMD must not:
Participants with Central Retinal Vein Occlusion must not:
Participants with Diabetic Macular Edema must not:
Study ID Numbers: | 040013, 04-EI-0013 |
Study First Received: | October 15, 2003 |
Last Updated: | August 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00071227 History of Changes |
Health Authority: | United States: Federal Government |
Age Related Macular Degeneration Macular Edema Inflammation Choroidal Neovascularization |
CRVO Diabetic Retinopathy Age Related Macular Edema AMD |
Anti-Inflammatory Agents Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Edema Hormones Triamcinolone hexacetonide Macular Edema Triamcinolone Acetonide Retinal Vein Occlusion Triamcinolone Venous Thrombosis Retinal Diseases Eye Diseases |
Vascular Diseases Retinal Degeneration Macular Degeneration Triamcinolone diacetate Immunosuppressive Agents Glucocorticoids Thrombosis Inflammation Choroidal Neovascularization Diabetic Retinopathy Embolism and Thrombosis Embolism Neovascularization, Pathologic |
Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Triamcinolone hexacetonide Triamcinolone Acetonide Retinal Vein Occlusion Therapeutic Uses Triamcinolone Cardiovascular Diseases Venous Thrombosis |
Retinal Diseases Eye Diseases Vascular Diseases Retinal Degeneration Macular Degeneration Triamcinolone diacetate Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents Thrombosis Pharmacologic Actions Embolism and Thrombosis |