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Laser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema

NCT02229175 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2020-07-31

No results posted yet for this study

Summary

Currently, diabetic macular edema is treated is through injection of a medications such as off-label bevacizumab, which decreases the swelling in the retina. These injections are sometimes required monthly until the condition is controlled. Recently, there have been some new FDA approved treatments using laser that decrease the swelling. These approximately ten minute treatments do not require injections and don't cause permanent damage to the eye, and they may decrease the number of injections one needs to get to treat diabetic macular edema (DME).

The purpose of this randomized clinical trial is to determine whether subvisible laser in combination with intravitreal bevacizumab is non-inferior compared to current standard of care (intravitreal bevacizumab alone) in achieving favorable outcomes for visual acuity, mean macular thickness, and patient quality of life, and has fewer needed intravitreal bevacizumab injections throughout the course of the 12 month study period.

Conditions

Interventions

DRUG

bevacizumab

intravitreal injections of antibodies inhibiting vascular endothelial growth factor

DEVICE

PASCAL Endpoint Management (EpM) laser treatment

This is an algorithm that is included in the PASCAL 577 mm yellow laser system (Topcon, Santa Clara, CA). This is FDA-approved for treatment of diabetic retinopathy and diabetic macular edema.

Sponsors & Collaborators

Principal Investigators

  • Jay Stewart, MD · University of California, San Francisco

  • Daniel Chao, MD, PhD · University of California, San Diego

  • Catherine Psaras, BA · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2026-01-01
Completion
2027-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229175 on ClinicalTrials.gov