Protocol Number: 04-EI-0013

Title:

Pilot Study of Intravitreal Injection of Triamcinolone Acetonide Formulation for Retinal Vascular Disorders

Number:

04-EI-0013

Summary:

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:

- Choroidal neovascularization associated with age-related macular degeneration (50 years of age and older)

- Macular edema associated with retinal vein occlusion (18 years of age and older)

- Diabetic macular edema ((18 years of age and older)

Participants undergo the following tests and procedures:

- Medical history and physical examination

- Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils will be 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.

- Indocyanine green angiography to identify feeder vessels that may be supplying abnormal blood vessels. This procedure is similar to fluorescein angiography, but uses a green dye and flashes an invisible light.

- Optical coherence tomography to measure retinal thickness. This test shines a light into the eye and produces cross-sectional pictures of the retina. These measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same.

- Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to allow examination and photography of the back of the eye.

- Triamcinolone acetonide injection to treat the eye. A numbing eye drop, an antibiotic eye drop, and an injected antibiotic are put in the eye before triamcinolone acetonide is injected into the eye's vitreous (jelly-like substance inside the eye). After the injection, the patient lies on his or her back for 30 minutes. An antibiotic eye ointment is used for 2 days following treatment.

- Blood tests to measure liver and kidney function.

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.

Sponsoring Institute:

National Eye Institute (NEI)

Recruitment Detail

Type: Follow-up Of Previously Enrolled Subjects Only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions: Currently Not Provided

Disease Category:

PROTICD

Keywords:

Age Related Macular Degeneration

Macular Edema

Inflammation

Choroidal Neovascularization

CRVO

Diabetic Retinopathy

Age Related Macular Edema

AMD

Recruitment Keywords:

None

Conditions:

Macular Degeneration

Retinal Vein Occlusion

Investigational Drug(s):

Triamcinolone Acetonide (TAC-PF)

Investigational Device(s):

None

Contacts:

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:

Aiello LP, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7.

Ando N, et al. Localization and quantitation of blood-retinal barrier breakdown in experimental proliferative vitreoretinopathy. Arch Ophthalmol. 1994 Jan;112(1):117-22. Erratum in: Arch Ophthalmol 1994 Jun;112(6):789.

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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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