Injected Ranibizumab to Treat Macular Telangiectasia Without New Blood Vessel Formation

NCT00457145 | Completed Phase 1

• 2 other identifiers: 07009607-EI-0096
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether the drug ranibizumab is an effective treatment for macular telangiectasia, a condition in which existing blood vessels near the macula (the back part of the eye responsible for sharp central vision) become dilated and twisted, and new abnormal blood vessels may form under the retina. Both the existing dilated vessels, as well the new subretinal vessels can leak fluid and blood, distort the retina, and affect vision. This study will see if ranibizumab can slow or stop the leakage and growth of existing, dilated, macular vessels in cases where new vessel formation under the retina is absent. Patients 18 years of age and older who have macular telangiectasia without new blood vessel formation may be eligible for this study. Visual acuity must be 20/40 or worse. Participants receive at least four injections of ranibizumab into the eye over a 12-week period. After the fourth injection, additional injections may be given every 4 weeks for up to 1 year if the doctor determines that they may be of benefit. In addition to ranibizumab treatment, patients undergo the following procedures:

• Medical history and physical examination.
• Eye examination, including dilation of the pupils and measurement of the fluid pressure in the eye.
• Fluorescein angiogram: A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Photographs of the retina are taken with a special camera that flashes a blue light into the eye. The photos show whether any dye has leaked from the vessels into the retina.
• Indocyanine green angiography: This procedure identifies feeder vessels that may be supplying the abnormal blood vessels. The test is similar to fluorescein angiography, but uses a green dye and flashes an invisible light.
• Autofluorescence imaging: This test examines how well the retina functions. The back of the eye is photographed with a bright light.
• Optical coherence tomography: This test measures retinal thickness. A light shined into the eye produces cross-sectional pictures of the retina. The measurements are repeated during the study to determine if retinal thickening is getting better or worse, or staying the same.
• Stereoscopic color fundus photography: The pupils are dilated and special photographs of the inside of the eye are taken to evaluate the retina and measure changes that occur over time. The camera flashes a bright light into the eye for each picture.
• Follow-up visits: The doctor evaluates the effects of the study treatment before and after each injection. Patients are contacted by phone 3 days after each injection to check on any treatment side effects. A final follow-up visit is scheduled 8 weeks after the last treatment.

Conditions

Telangiectasia

Keywords

Hyperfluorescence on Fluorescein; Idiopathic Juxtafoveal Telangiectasia; Retinal Edema/Thinning; Vascular Endothelial Growth Factor; Macular Telangiectasia

Interventions

Ranibizumab DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must understand and sign the informed consent.
• Participant must be at least 18 years of age.
• Participant must have macular telangiectasia in both eyes.
• Participant must have vision loss of 20/40 or worse.
• Participant must have clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography.
• All women of childbearing potential must have a negative urine pregnancy test at baseline, and be willing to undergo testing immediately prior to each injection and monthly for at least 2 months following the last dose of ranibizumab.
• Women of child-bearing potential who are sexually active and men who are sexually active are required to use two forms of birth control during the course of the study.

You may not qualify if:

• Participant has neovascularization in either eye.
• History (within past 5 years) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrythmias requiring ongoing treatment).
• History of stroke within 12 months of study entry.
• History within the past five years of a chronic ocular or periocular infection (including any history of ocular herpes zoster).
• Current acute ocular or periocular infection.
• Any major surgical procedure within one month of study entry.
• Known serious allergies to fluorescein dye.
• Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab, anecortave acetate, Protein Kinase C inhibitors, etc.).
• Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye.
• History of vitrectomy surgery in the study eye.
• History of glaucoma filtering surgery in the study eye.
• History of corneal transplant in the study eye.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Gass JD. Histopathologic study of presumed parafoveal telangiectasis. Retina. 2000;20(2):226-7. doi: 10.1097/00006982-200002000-00028. No abstract available.

  PMID: 10783967 BACKGROUND

MeSH Terms

Conditions

Telangiectasis; Idiopathic Juxtafoveal Retinal Telangiectasia; Papilledema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 5, 2007
• Study Start: March 27, 2007
• Study Completion: October 24, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-10-24

Locations

US (1)