Triamcinolone Acetonide Plus Laser Therapy to Treat Age-Related Macular Degeneration

Completed · Phase 3

Conditions studied: Macular Degeneration

In brief

This study will test the safety and effectiveness of combining a laser treatment called photodynamic therapy, or PDT, with injections into the eye of the steroid triamcinolone acetonide for treating age-related macular degeneration (AMD). The macula is the part of the retina in the back of the eye that determines central or best vision. AMD can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. This vision loss is caused by the formation of abnormal blood vessels behind the retina that leak blood under the macula. PTD stops the growth of these blood vessels and slows the rate of vision loss; however, it has only a temporary effect and does not work in all patients. Furthermore, it may actually cause some swelling and re-growth of blood vessels. Triamcinolone acetonide can help lessen swelling and scarring. Patients 50 years of age and older with AMD may be eligible for this study. Candidates are screened with a medical history, medical evaluation, and eye examinations (see below). Participants are randomly assigned to one of three treatment groups: 1) PDT plus 1 mg TAC-PF; 2) PDT plus 4 mg TAC-PF; or 3) PDT plus sham injection (a syringe with no needle is pressed against the eye). Treatments are given the day the patient enrolls in the study and then every 3 months for 2 years, as long as the therapy is thought beneficial. Patients who must discontinue TAC-PF injections may still be treated with PDT if medically necessary. In addition to treatment, patients undergo the following tests and procedures: * Eye examination: Visual acuity and eye pressure are measured, and the lens, retina, pupils and eye movements are examined. * Fundus photography: Photographs of the back of the eye are taken using a special camera with a bright flash. * Lens photography: Photographs of the lens are taken to look for development of cataracts. * Fluorescein angiography: Pictures of the retina are taken to look for abnormal blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. The retina is photographed 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: This test uses light to produce a 2-dimensional cross-sectional picture of the retina. The patient looks into a machine called an optical coherence tomograph at a pattern of flashing and rotating red and green lights, first with one eye and then the other. * PDT: A needle is placed in an arm vein and a drug called verteporfin (Visudyne® (Registered Trademark)) is infused into the vein over 10 minutes. After 15 minutes, the eye is anesthetized with numbing drops. A special contact lens is then placed on the eye and the laser beam is directed to the eye for 83 seconds. * TAC-PF or injections (for those in the TAC-PF treatment groups): Numbing and anesthetic drops are placed on the surface of the eye before injection of TAC-PF. Another anesthetic is then applied to the lower part of the eye with a cotton swab. After a few minutes, TAC-PF is injected into the vitreous (jelly-like substance inside the eye). Patients receiving sham injections undergo the identical procedure, except a syringe with no needle is pressed against the eye to seem like a real injection. All patients receive antibiotic drops to put in their eye for 2 days after each treatment. Patients return to the clinic anytime from 2 to 7 days after each treatment for a check of vision, eye pressure, and treatment side effects. Patients are seen in the clinic for additional checks at 4 weeks and 4 months after the first treatment.

Key facts

Study ID: NCT00100009
Run by: National Eye Institute (NEI)
People needed: 30
Starts: 2004-12-09
Expected to finish: 2006-12-20
Last updated by the study team: 2017-07-02

Who can join

Age: 50 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Participants meeting any of the following criteria will be excluded from the study:
Choroidal neovascularization, in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.
Presence of geographic atrophy under the fovea in the study eye.
Evidence of retinal angiomatous proliferation as suspected by the presence of intraretinal hemorrhage, intraretinal leakage, adjoining serous PED or the presence of a connecting retinal vessel.
The presence of a chorio-retinal anastomosis.
Decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non-proliferative diabetic retinopathy, or proliferative diabetic retinopathy.
Decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; a tear (rip) of the RPE; a vitelliform-like lesion of the outer retina (e.g., as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy.
Presence of fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring greater than 50% of the CNV lesion.
History of other antiangiogenic treatment or treatment for CNV (not including photodynamic therapy and pegaptanib sodium injections) in the study eye with transpupillary thermotherapy or other local treatment (such as submacular surgery). Previous laser photocoagulation therapy is acceptable, provided it was not subfoveal.
History of photodynamic therapy (PDT) within 1 year of enrollment.
Current exam evidence of ocular toxoplasmosis; pseudoexfoliation; external ocular infection, including conjunctivitis; chalazion; significant blepharitis; or aphakia in the study eye (pseudophakic participants are eligible).
History of ocular hypertension if intraocular pressure (IOP) is greater than or equal to 25 mm Hg, the participant is on Cosopt with one or more other topical glaucoma medications or is on greater than 2 topical glaucoma medications, not including Cosopt; the most recent visual field, performed within the last 12 months, is abnormal and not attributable to the participant's macular disease; and the optic disc appears glaucomatous.
Intraocular surgery (including lens replacement surgery) within 6 weeks prior to randomization.
Recent history of (within the last 6 months), or current acute ocular or periocular infection (including any history of ocular herpes zoster or simplex).
History of prior treatment with intravitreal corticosteroids.
History of peribulbar steroid injection within 6 months prior to randomization.
History of oral steroid use at any time during the 30 days prior to randomization.
History of untoward complications from corticosteroid therapy, including elevated intraocular pressure in response to topical or periocular corticosteroids that required IOP-lowering treatment.
Known hypersensitivity/allergy to verteporfin, porfimer sodium, or other porphyrins, porphyria or other porphyrin sensitivity, or hypersensitivity to sunlight or bright artificial light.
Participation in any other clinical study or are receiving, or have received any experimental systemic treatment for AMD (e.g.: retinoic acid, thalidomide) or any other investigational new drug within 12 weeks prior to the start of study treatment.
Medical problems that make consistent follow-up over the treatment period unlikely (e.g. stroke, severe MI, end stage malignancy), any contraindications to performing the necessary diagnostic studies (i.e., known allergy to fluorescein dyes, etc.), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections.
History of moderate to severe abnormal liver function, unless documented evidence of normal liver enzymes is provided.

Where it is running

Retina Associates Southwest (RASTA) — Tucson, Arizona, United States
Doheny Eye Institute — Los Angeles, California, United States
Bascom Palmer Eye Institute — Miami, Florida, United States
Central Florida Retina (CFROL) — Orlando, Florida, United States
Retina Associates of Florida — Tampa, Florida, United States
Midwest Eye Institute — Indianapolis, Indiana, United States
Elman Retina Group, P.A. - Baltimore (ERGBM) — Baltimore, Maryland, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Elman Retina Group, P.A. - Pikesville (ERGPM) — Pikesville, Maryland, United States
University of Michigan — Ann Arbor, Michigan, United States
VitreoRetinal Surgery (VRSMN) Center — Minneapolis, Minnesota, United States
Cornell University — New York, New York, United States
Duke University Eye Center (DUENC) — Durham, North Carolina, United States
Dean McGee Eye Institute (DMEIO) — Oklahoma City, Oklahoma, United States
Casey Eye Institute-Portland, OR (CEIPO) — Portland, Oregon, United States
Retina Northwest (RNWPO) — Portland, Oregon, United States
Wills Eye Hospital — Philadelphia, Pennsylvania, United States
Southeastern Retina Associates (SRAKT) — Knoxville, Tennessee, United States
Vanderbilt University — Nashville, Tennessee, United States
Texas Retina Associates — Arlington, Texas, United States
Texas Retina Associates — Dallas, Texas, United States
Retina Group of Washington - Fairfax (RGWFF) — Fairfax, Virginia, United States
University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.