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Laser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT02229175
Recruitment Status : Not yet recruiting
First Posted : September 1, 2014
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: bevacizumab Device: PASCAL Endpoint Management (EpM) laser treatment Phase 2 Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Subvisible Retinal Laser Therapy With Intravitreal Bevacizumab in Treatment of Diabetic Macular Edema
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Bevacizumab

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 Name: 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 Name: Avastin




Primary Outcome Measures :
  1. Retinal thickness [ Time Frame: 12 months ]
    Change in retinal thickness on SD-OCT from baseline to 12 months.


Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 12 months ]
    Change in Snellen visual acuity from baseline to 12 months.

  2. Number of injections of bevacizumab needed [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229175


Contacts
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Contact: Jay Stewart, MD 415-206-3123 stewartj@vision.ucsf.edu
Contact: Catherine Psaras, BA 415-206-3123 Catherine.Psaras@ucsf.edu

Locations
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United States, California
San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94110
Contact: Catherine D Psaras, BA    415-206-3123    Catherine.Psaras@ucsf.edu   
Principal Investigator: Jay Stewart, MD         
Sub-Investigator: Daniel Chao, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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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

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02229175     History of Changes
Other Study ID Numbers: 14-14153
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Diabetic Macular Edema
Diabetic Retinopathy
Type 1 Diabetes
Type 2 Diabetes
Macular Edema
bevacizumab
intravitreal injection
Avastin
PASCAL Endpoint Management (EpM) system
Subthreshold focal laser treatments
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors