Laser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT02229175
Phase
PHASE2/PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    intravitreal injections of antibodies inhibiting vascular endothelial growth factor
  • PASCAL Endpoint Management (EpM) laser treatment — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Sep 1, 2014
Start date
Jan 1, 2021
Status verified
Jul 2020
Primary completion
Jan 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Retinal thickness [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco General HospitalSan FranciscoCalifornia94110-

Find similar trials in San Francisco, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
San Francisco General Hospital· San Francisco, CA

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