NCT02229175

Laser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2014-09-01
• Last updated: 2020-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study