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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00711490 |
This study will test whether sirolimus, a drug approved to treat psoriasis and other conditions, can help patients with diabetic macular edema. In this disorder, blood vessels in the retina (a thin layer of tissue that lines the back of the eye) become leaky and the retina swells. The macula, the center part of the retina that is responsible for fine vision, may also swell and cause vision loss. Sirolimus inhibits a protein in the body called mTOR, which plays a critical role in regulating how cells divide and grow. Sirolimus is also believed to affect the inflammatory process. For both these reasons, the drug may be helpful in treating diabetic macular edema.
Patients 18 years of age and older with diabetic macular edema may be eligible for this study. Candidates are screened with the following tests and procedures:
Special photographs of the inside of the eye are taken using a camera that flashes a bright light into the eye.
Participants undergo the following procedures:
Patients who require treatment in the non-study eye receive an FDA-approved treatment such as laser photocoagulation.
Condition | Intervention | Phase |
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Diabetic Retinopathy |
Drug: Sirolimus Drug: Rapamycin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Pilot Study of the Evaluation of Sirolimus in the Treatment of Diabetic Macular Edema |
Estimated Enrollment: | 8 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Objective: Diabetic macular edema (DME) is a frequent manifestation of diabetic retinopathy, a leading cause of blindness in the United States. The only proven treatment for DME is laser photocoagulation. Sirolimus has been shown to inhibit the production, signaling and activity of many growth factors relevant to the development of diabetic retinopathy. Therefore, tthis study will investigate the safety and efficacy of multiple sirolimus injections in patients with DME.
Study Population: Eligibility criteria include central macular thickening > 260 microns and visual acuity 20/32 or worse in one or both eyes.
Design: Five participants will be enrolled into this open-label pilot study. After receiving two 20 microL (440 micrograms) subconjunctival injections in the study eye at baseline and Month 2, the participants will be re-evaluated every two months for at least one year for possible additional injections. During follow-up, participants will not undergo re-injection if they show significant clinical improvement, defined as no intraretinal fluid or cysts present on optical coherence tomography (OCT) OR 100% reduction in excess retinal thickness over 225 microns on OCT OR no leakage on fluorescein angiography (FA). Beginning at Month 4, participants will be assessed for treatment failure, defined as loss of 15 or more letters of vision compared to baseline at two consecutive visits OR a 50% or greater increase in total retinal thickness as measured by OCT at 2 consecutive visits. Individual participants will be required to suspend treatment and withdraw from study therapy at any visit in which they are deemed a treatment failure. Participants will have the option of continuing treatment until a common termination date of one year.
Outcome Measures: The primary outcome is the change in visual acuity in the study eye at six months compared to baseline. Secondary outcomes include changes in visual acuity in the study eye at one year as compared with baseline, and changes in retinal thickness as measured by OCT and changes in fluid leakage in the macula as demonstrated by FA at six months, one year and throughout the study period in the study and fellow eyes. Safety outcomes include number and severity of systemic and ocular toxicities, adverse events and infections, and the number of participants withdrawn from study therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Diagnosis of diabetic mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present:
Both female participants of childbearing potential and male participants able to father a child must agree to practice two forms of adequate birth control throughout the course of the study and for three months following the completion of the study treatment. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine divice, barrier methods with spermicide (diaphram with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy).
EXCLUSION CRITERIA:
History of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years that could be worsened by immunosuppression*.
STUDY EYE CRITERIA:
The participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below.
STUDY EYE INCLUSION CRITERIA:
STUDY EYE EXCLUSION CRITERIA:
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 ( Catherine Meyerle, M.D./National Eye Institute ) |
Study ID Numbers: | 080175, 08-EI-0175 |
Study First Received: | July 8, 2008 |
Last Updated: | September 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00711490 History of Changes |
Health Authority: | United States: Federal Government |
Diabetic Macular Edema Diabetic Retinopathy Rapamycin Sirolimus |
Diabetic Macular Edema Diabetic Retinopathy Diabetes |
Sirolimus Anti-Infective Agents Immunologic Factors Eye Diseases Diabetes Mellitus Vascular Diseases Edema Endocrine System Diseases Macular Degeneration Retinal Degeneration |
Immunosuppressive Agents Diabetic Angiopathies Anti-Bacterial Agents Macular Edema Diabetic Retinopathy Antifungal Agents Endocrinopathy Retinal Diseases Diabetes Complications |
Sirolimus Anti-Infective Agents Immunologic Factors Antineoplastic Agents Eye Diseases Physiological Effects of Drugs Vascular Diseases Diabetes Mellitus Endocrine System Diseases Macular Degeneration Retinal Degeneration Antibiotics, Antineoplastic |
Immunosuppressive Agents Pharmacologic Actions Diabetic Angiopathies Anti-Bacterial Agents Macular Edema Diabetic Retinopathy Antifungal Agents Therapeutic Uses Cardiovascular Diseases Retinal Diseases Diabetes Complications |