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NCT01610557 · ClinicalTrials.gov registry record · Phase 2
Ranibizumab and Bevacizumab for Diabetic Macular Edema
A Phase 2 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT01610557: Completed Phase 2 study, sponsored by National Eye Institute (NEI).
NCT01610557 is a Phase 2 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01610557, a Phase 2 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
Background: * Diabetic macular edema is a common eye complication of diabetes. It causes the blood vessels in the retina at the back of the eye to leak, causing swelling. The macula is the center part of the retina that is important for seeing fine details and for tasks such as reading, driving, or sewing. Swelling of the macula leads to vision loss and possible blindness. Inflammation may play a role in diabetic macular edema. It is also possible that there is a problem with the blood vessels and the blood supply to cells of the retina. * A chemical in the body called vascular endothelial growth factor (VEGF) is important in the formation of blood vessels in the body. Lowering VEGF levels may help treat diabetic macular edema by reducing abnormal leaking blood vessels in the eye. Drugs that can lower or block VEGF include ranibizumab and bevacizumab. Both drugs have been shown to help treat diabetic macular edema. Researchers want to see if one of the drugs works better than the other. Objective: To compare the effectiveness of ranibizumab and bevacizumab injections for diabetic macular edema. Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye. Design: * Participants will be screened with a physical exam and medical history. A full eye exam will be performed. Blood and urine samples will be collected. * One eye will be selected as the study eye to receive treatment. If both eyes are affected, both eyes may be enrolled in the study and receive different drug treatments. * The main part of the study will last for 9 months. At each study visit, participants will have physical exams and eye exams. They will answer questions about their health and any side effects from the drugs. * Participants will be assigned to one of four groups. Two groups will have two series of ranibizumab and one series of bevacizumab shots. The other two groups will have two series of bevacizumab and one series of ranibizumab shots. A seri
Primary Outcome
The primary outcome for 3-months change in BCVA utilized data from Weeks 12, 24 and 36 aggregated in a linear mixed-effects model. This model included adjustments accounting for period (i.e., Weeks 12, 24 and 36), treatment in current period, treatment in prior period, and baseline BCVA to provide the estimated 3-month BCVA change. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the le
Interventions
- DRUG Bevacizumab
- DRUG Ranibizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
What the finished NCT01610557 record still lists
NCT01610557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT01610557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01610557 about?
NCT01610557 is a clinical study titled "Ranibizumab and Bevacizumab for Diabetic Macular Edema". Background: * Diabetic macular edema is a common eye complication of diabetes. It causes the blood vessels in the retina at the back of the eye to leak, causing swelling. The macula is the center part of the retina that is important for seeing fine details and for tasks such as reading, driving, or...
What is the current status of trial NCT01610557?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2012-05. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01610557?
The interventions under investigation include: Bevacizumab (DRUG), Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT01610557?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01610557's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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