Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Eye Institute (NEI) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00304954 |
This study will examine whether the anti-inflammatory medicines infliximab, sirolimus or daclizumab, when given with a patient's current therapies, will prevent the growth of new blood vessels in the eye in patients with age-related macular degeneration (AMD).
Patients 55 years of age and older with AMD with drusen larger than 63um may be eligible for this study. Vision in the study eye must be between 20/20 and 20/400.
Participants are randomly assigned to one of three treatments - infliximab, sirolimus, or daclizumab - or to observation only. In addition, patients may be treated by their ophthalmologist as need for their AMD. Infliximab and daclizumab are given intravenously (through a vein); infusions are given at enrollment in the study, then at 2 weeks, and then monthly. Sirolimus is a pill that is taken every other day for the duration of the study. At 6 months patients are evaluated to see if continuing treatment would be beneficial.
In addition to treatment or observation, participants undergo the following procedures:
Physical examination at enrollment and 6 months.
Photos of the back of the eye, fluorescein angiography, indocyanine green studies, and measurement of retinal thickness at enrollment and months 1, 3 and 6.
Tuberculin skin test and chest x-ray at enrollment and 6 months.
Blood tests at enrollment and months 1, 3 and 6.
Condition | Intervention | Phase |
---|---|---|
Macular Degeneration Neovascularization |
Drug: Daclizumab Drug: Infliximab Other: Observation Drug: Sirolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Choroidal Subretinal Neovascularization With Agents Directed Against the Immune Response |
Estimated Enrollment: | 20 |
Study Start Date: | March 2006 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Biologic directed against parts of the immune system.
|
Drug: Daclizumab
N/A
|
2: Active Comparator
Biologic directed against parts of the immune system.
|
Drug: Infliximab
N/A
|
3: Active Comparator
Medication directed again parts of the immune system and new blood vessels.
|
Drug: Sirolimus
N/A
|
4
Observation with standard care.
|
Other: Observation
N/A
|
There has been much interest in the possible role of the immune system in age related macular degeneration. Experimental models and patient material have, to date, suggested a role for macrophages and complement. We hypothesize that the underlying mechanism that leads to choroidal neovascularization (CNV) is similar to those at play in atherosclerosis. If this is the case, then CNV treatment should be amenable to new immunomodulatory agents directed against specific parts of the immune system.
After therapy with anti-angiogenic agents not leading to a persistent remission of choroidal neovascularization due to age related macular degeneration, participants will be treated with one of three immunomodulatory agents or will be observed in conjunction with their continued anti-angiogenic therapy. Thus the participant will continue with the anti-angiogenic therapy they are receiving after randomization. We hypothesize that this combination therapy will inhibit progression of choroidal neovascularization (CNV) associated with age related macular degeneration (AMD).
This is an open-label, phase II, randomized, single center clinical trial of 20 study participants randomized to receive one of three immunomodulatory agents or will be observed in conjunction with their anti-angiogenic therapy.
Ages Eligible for Study: | 55 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
To be eligible for the study, participants must fulfill all of the following criteria:
In the study eye, the presence of choroidal neovascularization under the fovea determined by NEI Investigators and defined as any one of the following fluorescein angiographic (FA) features:
For all CNV lesions considered to have occult CNV with no classic CNV, one of the following criteria must be met:
A documented loss of visual acuity (5 or more letters of best-corrected visual acuity if both measurements are made using an ETDRS chart or, a doubling of the visual angle if Snellen acuities are available from either an outside referral center or within the participating center (e.g., 20/80 to 20/160) a doubling of the visual angle is required because of the measurement variability of Snellen acuities).
OR
Documented fluorescein angiographic evidence of a 10% increase in the lesion greatest linear dimension over the 3 months prior to enrollment.
OR
EXCLUSION CRITERIA:
Participants meeting any of the following criteria will be excluded from the study:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | National Institutes of Health ( Robert B. Nussenblatt, M.D./National Eye Institute ) |
Study ID Numbers: | 060111, 06-EI-0111 |
Study First Received: | March 17, 2006 |
Last Updated: | December 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00304954 |
Health Authority: | United States: Federal Government |
Age-Related Macular Degeneration Ocular Inflammation Rapamycin Remicade Daclizumab Immunosuppression |
Infliximab Neovascularization Sirolimus Age-Related Macular Degeneration AMD Ocular Inflammation |
Sirolimus Infliximab Clotrimazole Eye Diseases Daclizumab Miconazole Tioconazole |
Macular Degeneration Retinal Degeneration Inflammation Metaplasia Neovascularization, Pathologic Retinal Diseases Retinal degeneration |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Antifungal Agents Antirheumatic Agents Dermatologic Agents |