Identification and Treatment of Feeder Vessels in Macular Degeneration

Completed · Phase 1

Conditions studied: Macular Degeneration

In brief

This study will try to identify and treat feeder vessels in age-related macular degeneration. The macula is the part of the retina in the back of the eye that determines central or best vision. In macular degeneration, leaking blood vessels under the macula lead to loss of central vision. These vessels branch out tree-like from one or more feeder vessels. Instead of treating all the abnormal branching vessels, this study will try to find and close only the feeder vessels, thereby depriving the abnormal vessels of nutrition. The vessels will be closed with laser beam treatment. People 50 years of age and older with macular degeneration and visual acuity worse than 20/50 in the study eye and the same or better vision in the other eye may be eligible for this study. Candidates will undergo fluorescein angiography to try to locate feeder vessels. For this procedure, a yellow dye is injected into an arm vein. The dye travels to the blood vessels in the eyes, and 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. Before laser treatment, participants will have a complete eye examination, including measurement of visual acuity, evaluation of the front part of the eye with a slit lamp microscope, examination of the retina with an ophthalmoscope, and measurement of eye pressure using a tonometer. During the laser treatment phase of the study, participants will have indocyanine green angiography-a procedure similar to fluorescein angiography, but using a green dye-to photograph the retina and identify feeder vessels. If feeder vessels are located, laser beam treatment will begin. For this procedure, the eye is anesthetized with numbing drops. A special contact lens is then placed on the eye for the laser treatment. The number of treatments depends on how well the individual patient responds, but usually between two and eight treatments are required. The indocyanine green angiogram will be repeated after the laser beam treatment to determine if the feeder vessels have been successfully closed. If the vessels remain partially open, a repeat application will be done, followed by another indocyanine green angiogram to check the results. Patients will be checked in the clinic after 1 week to see if additional treatment is needed. If so, re-treatment will be done in a week. If no re-treatment is required, follow-up visits will be scheduled 2, 3, and 6 weeks after treatment, 3 and 6 months after treatment, and every 6 months after that for 2 years to evaluate treatment results. The evaluations will include fluorescein angiograms and other examinations that were done before starting treatment. If abnormal vessels are still present or growing, repeat treatments will be applied following the same procedure.

Key facts

Study ID: NCT00018070
Run by: National Eye Institute (NEI)
People needed: 20
Starts: 2001-06-28
Expected to finish: 2006-08-30
Last updated by the study team: 2017-07-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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.
Decreased vision, in the study eye, due to retinal disease not attributable to CNVM, such as nonexudative forms of ARM, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane.
Decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina.
History of other antiangiogenic treatment with thalidomide or alpha interferon.
Any contraindications to performing the necessary diagnostic studies, especially the use of fluorescein or indocyanine green angiography.
Allergy to shellfish, iodine or previous iodine containing dyes.
Medical problems that make consistent follow-up over the treatment period unlikely (e.g. stroke, severe MI, terminal carcinoma).
Current use of or likely need for systemic or ocular medications known to be toxic to the lens, retina or optic nerve, such as:
Deferoxamine
Chloroquine/Hydroxychloroquine (Plaquenil)
Tamoxifen
Phenothiazine
Phenothiazines
Ethambutol
Well-defined choroidal neovascularization (as defined by the MPS) whose area, as seen on the early frames of the SFA, is greater than 50% of the total area of late leakage or staining as determined by the Principal Investigator.
Concomitant administration of other experimental therapies for AMD.

Where it is running

National Eye Institute (NEI) — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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