Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00711490 · ClinicalTrials.gov registry record · Phase 1
Sirolimus to Treat Diabetic Macular Edema
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00711490 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT00711490, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
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, this 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 a 20 μL (440 μg) subconjunctival injection 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 or treatment success, defined as no intraretinal fluid or cysts present on optical coherence tomography (OCT) OR 100% reduction in excess retinal thickness over 260 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 two consecutive visits. Individual participants deemed treatment failures will continue receiving sirolimus injections, but will be allowed to receive focal laser therapy for any amenable leaking microaneurysms at Month 4. Beginning at Month 6, focal laser therapy will be permitted for both treatment failures and participants who do not meet the criteria of a treatment success. Participants will have the option of continuing treatment until a common termination date of one year. Outcome Measures: The p
Interventions
- DRUG Sirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00711490
The ClinicalTrials.gov registry entry for NCT00711490 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sirolimus is the first listed.
NCT00711490 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00711490 about?
NCT00711490 is a clinical study titled "Sirolimus to Treat Diabetic Macular Edema". 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 facto...
What is the current status of trial NCT00711490?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2008-07. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00711490?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT00711490?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.