Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders
|First Received Date ICMJE||October 15, 2003|
|Last Updated Date||August 16, 2007|
|Start Date ICMJE||October 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00071227 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Eye Injections of Triamcinolone Acetonide for Retinal Blood Vessel Disorders|
|Official Title ICMJE||Pilot Study of Intravitreal Injection of Triamcinolone Acetonide Formulation for Retinal Vascular Disorders|
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:
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: Triamcinolone Acetonide (TAC-PF)|
|Study Arm (s)||Not Provided|
|Publications *||Arvas S, Ocakoglu O, Ozkan S. The capillary blood flow in ischaemic type central retinal vein occlusion: the effect of laser photocoagulation. Acta Ophthalmol Scand. 2002 Oct;80(5):490-4.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||August 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
All participants must:
INCLUSION CRITERIA - DISEASE-SPECIFIC:
Participants with neovascular AMD:
Participants with central retinal vein occlusion:
Participants with diabetic macular edema:
EXCLUSION CRITERIA - GENERAL:
All participants must not:
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:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00071227|
|Other Study ID Numbers ICMJE||040013, 04-EI-0013|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Eye Institute (NEI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2007|
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