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NCT01934556 · ClinicalTrials.gov registry record · Phase 1

A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema

A Phase 1 study of Diabetic Macular Edema, sponsored by Palmetto Retina Center.

Completed
Registry status
Phase 1
Development phase
150
Enrollment target
3
Study locations

NCT01934556 is a Phase 1 study of Diabetic Macular Edema that has completed, run by Palmetto Retina Center. The registered enrollment target is 150 participants, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT01934556, a Phase 1 study of Diabetic Macular Edema, has completed, sponsored by Palmetto Retina Center.

COMPLETED
Registry status
Phase 1
Development phase
150 participants
Enrollment target
3
Study locations

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

FieldValue
Enrollment Target 150 participants
Start Date 2013-11
Est. Completion 2018-04
Phase Phase 1

Sponsor

Palmetto Retina Center

2 total trials

What the Registry Record Tells You About NCT01934556

The ClinicalTrials.gov registry entry for NCT01934556 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (96% lower). The listed sponsor is Palmetto Retina Center, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT01934556 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, South Carolina, Texas.

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.

What interventions are being tested in trial NCT01934556?

The interventions under investigation include: Ranibizumab 0.3 mg intravitreal injection (DRUG), Guided Laser Photocoagulation (DEVICE).

Who is sponsoring clinical trial NCT01934556?

This trial is sponsored by Palmetto Retina Center, which has 2 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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