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A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema
NCT01934556 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with swelling of the retina from diabetes.
Conditions Studied
Interventions
- DRUG Ranibizumab 0.3 mg intravitreal injection
- DEVICE Guided Laser Photocoagulation
Study Locations (3)
California
- Retina-Vitreous Associates Medical Group — Beverly Hills
South Carolina
- Palmetto Retina Center — West Columbia
Texas
- Retina Consultants of Houston — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-11 |
| Est. Completion | 2018-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01934556
The ClinicalTrials.gov registry entry for NCT01934556 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Palmetto Retina Center, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions — of which Ranibizumab 0.3 mg intravitreal injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01934556 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, South Carolina, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01934556 about?
NCT01934556 is a clinical study titled "A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema". The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with swelling of the retina from diabete...
What is the current status of trial NCT01934556?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2013-11. Estimated completion is 2018-04.
What conditions does trial NCT01934556 study?
This clinical trial studies the following conditions: Diabetic Macular Edema. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01934556?
The interventions under investigation include: Ranibizumab 0.3 mg intravitreal injection (DRUG), Guided Laser Photocoagulation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01934556?
This trial is sponsored by Palmetto Retina Center, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01934556 being conducted?
This trial has 3 study locations across California, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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