Neovascularization Clinical Trial
Official title:
Pilot Study of Intravitreal Injection of Ranibizumab for Macular Telangiectasia With Neovascularization (MACTEL 1)
Verified date | April 12, 2011 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will examine whether the drug ranibizumab (Lucentis) can help prevent vision loss
in people with macular telangiectasia, a condition in which new blood vessels grow in the
retina at the back of the eye and can leak. Such changes in blood vessels are seen in other
diseases associated with changes in a body chemical called vascular endothelial growth factor
(VEGF). Ranibizumab is an anti-VEGF drug that is effective in treating another eye disease,
age-related macular degeneration, with similar changes in eye blood vessels.
People 18 years of age and older with macular telangiectasia in both eyes and new blood
vessel growth in at least one eye may be eligible for this study. They must have vision
better than 20/400 in the study eye.
Participants undergo the following procedures:
- Ranibizumab injections in the study eye at least four times over 12 weeks. Depending on
the response to treatment and the side effects, additional injections may be given every
4 weeks for up to 1 year. The eye is numbed before the injection and the eye area is
cleaned with an antiseptic. Antibiotic drops are used for 3 days following the injection
to prevent infection.
- Evaluations before starting treatment, at the time of each injection, and 8 weeks after
the last treatment:
- History and physical examination.
- Eye examination with dilation, microperimetry and photography: The eye examination
measures visual acuity, eye pressure and eye movements. For the microperimetry
test, subjects sit in front of a computer screen and press a button when they see a
light on the screen. Measurements and photographs of the retina are also taken.
- Fluorescein and indocyanine green angiography to examine the blood vessels in the
eye: A dye called fluorescein or indocyanine green is injected into a vein in the
arm. The dye travels through the veins to the blood vessels in the eyes. A camera
takes pictures of the dye as it flows through the blood vessels.
- Pregnancy test: Women who are able to become pregnant have a urine pregnancy test
before each ranibizumab injection.
Status | Completed |
Enrollment | 1 |
Est. completion date | April 12, 2011 |
Est. primary completion date | April 12, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: - 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 neovascularization in the study eye. - Participant must have vision loss of better than 20/400 in the study eye. - Participant must have clear ocular media and adequate pupillary 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. - Safety and toxicity of ranibizumab have not yet been investigated in children. Further, it is unlikely that younger participants will be able to comply with all examinations and intravitreal injections. Therefore, participants below the age of 18 will be excluded from participation in the study. This ocular condition is not commonly found in participants below the age of 18. EXCLUSION CRITERIA: - History (within past five years) of a myocardial infarction or cerebrovascular accident or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within six months prior to baseline, atrial or ventricular tachyarrythmias requiring ongoing treatment). - History of stroke within 12 months of study entry. - History within the past 30 days 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 AND either indocyanine green dye iodine, or shellfish. Indocyanine green dye is contraindicated in patients with iodine and shellfish allergies. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, 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. — View Citation
Amin R, Puklin JE, Frank RN. Growth factor localization in choroidal neovascular membranes of age-related macular degeneration. Invest Ophthalmol Vis Sci. 1994 Jul;35(8):3178-88. — View Citation
Boulton M, Foreman D, Williams G, McLeod D. VEGF localisation in diabetic retinopathy. Br J Ophthalmol. 1998 May;82(5):561-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of intravitreal ranibizumab treatment on visual acuity. | |||
Secondary | ETDRS BCVA, area of retinal leakage, retinal thickness, area of hypofluoresence, central retinal sensitivity. |
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