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Identification and Treatment of Feeder Vessels in Macular Degeneration

NCT00018070 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Macular Degeneration

Interventions

PROCEDURE

Angiography

PROCEDURE

Laser Treatment

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Study Design

Purpose
TREATMENT

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-28
Completion
2006-08-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00018070 on ClinicalTrials.gov