Laser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema

July 29, 2020 updated by: University of California, San Francisco

Comparison of Subvisible Retinal Laser Therapy With Intravitreal Bevacizumab in Treatment of Diabetic Macular Edema

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The patient is randomized into one of two study groups described below.

  • Group 1: Intravitreal bevacizumab (IVB) will be administered at the first 3 monthly visits and subvisible laser treatment will be administered at the first visit. The the patient will undergo monthly visits, as he/she would with standard of care treatment, allowing for retreatment with monthly IVB and laser treatment every 3 months if defined retreatment criteria are met, as determined by a physician.
  • Group 2: Intravitreal bevacizumab (IVB) will be administered at the first 3 monthly visits. The patient will then undergo monthly exams, as he or she would with standard of care treatment, allowing for retreatment with monthly IVB if defined retreatment criteria are met, as determined by a physician. The patient may also undergo sham laser treatment (he/she will be placed in front of laser but no laser will be activated) so that the patient isn't made aware of which treatment group he/she is a part of.

Other data that will be collected throughout the study at monthly examinations:

  • Monthly Snellen Visual acuity test
  • Monthly spectral-domain optical coherence tomography (SD-OCT) imaging using standard clinic protocol monthly
  • Standard clinic diabetic montage Fundus photos at months 0,6,12
  • Fluorescein angiography at months 0, 6, 12

The subjects' visit schedules will be the same as for routine standard of care for the IVB injection procedure. There are no additional appointments for this study.

All study procedures will be done at San Francisco General Hospital

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria include adults ≥ 18 years with type 1 or 2 diabetes mellitus with DME secondary to diabetes mellitus involving the center of the macula in the study eye and with a decrease in vision is determined to be primarily the result of DME in the study eye. The study eye must have a BCVA ETDRS letter score of 50 to 24 (20/30 to 20/320) in the study eye. The patient should be on a stable medical diabetic regimen that is not expected to change.

Exclusion Criteria:

  • Patients are excluded if they have had laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1, more than two previous macular laser treatments in the study eye, previous use of intraocular or periocular corticosteroids in the study eye within 90 days of Day 1, previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab, or aflibercept) within 45 days of Day 1, active proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR, uncontrolled diabetes mellitus, as defined by HbA1c > 12%, or a patient who is functionally monocular, as defined by the clinician or vision worse than 20/400 in the fellow eye even if that eye is otherwise eligible for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IVB + laser
Intravitreal bevacizumab (IVB) will be administered at baseline, month 1, and month 2, consistent with previous DME trials. Subvisible laser treatment will be administered at baseline. Patients will then undergo monthly surveillance, as they would with standard of care treatment, allowing for retreatment with monthly IVB and laser therapy every 3 months if defined retreatment criteria are met, as described below.
Drug: bevacizumab
intravitreal injections of antibodies inhibiting vascular endothelial growth factor
Other Names:
  • Avastin
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.
ACTIVE_COMPARATOR: IVB only
IVB monthly at baseline, month 1, and month 2. Patients will then undergo monthly surveillance, as they would with standard of care treatment, allowing for retreatment with monthly IVB if defined retreatment criteria are met, as described below. Patients will also undergo sham laser treatment (patient will be placed in front of laser but no laser will be activated) to mask the patient to the treatment.
Drug: bevacizumab
intravitreal injections of antibodies inhibiting vascular endothelial growth factor
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal thickness
Time Frame: 12 months
Change in retinal thickness on SD-OCT from baseline to 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 12 months
Change in Snellen visual acuity from baseline to 12 months.
12 months
Number of injections of bevacizumab needed
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Jay Stewart, MD, University of California, San Francisco
  • Principal Investigator: Daniel Chao, MD, PhD, University of California, San Diego
  • Study Director: Catherine Psaras, BA, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

January 1, 2026

Study Completion (ANTICIPATED)

January 1, 2027

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (ESTIMATE)

September 1, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-14153

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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