Laser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema

NCT02229175 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 14-14153
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Retinal thickness

  Change in retinal thickness on SD-OCT from baseline to 12 months.

  12 months

Secondary Outcomes (2)

• Visual Acuity

  12 months

• Number of injections of bevacizumab needed

  12 months

Study Arms (2)

IVB + laser

EXPERIMENTAL

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; Device: PASCAL Endpoint Management (EpM) laser treatment

IVB only

ACTIVE COMPARATOR

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

Interventions

bevacizumab DRUG

intravitreal injections of antibodies inhibiting vascular endothelial growth factor

Also known as: Avastin

IVB + laser; IVB only

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.

IVB + laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Macular Edema

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jay Stewart, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Daniel Chao, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Catherine Psaras, BA

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: September 1, 2014
• Study Start: January 1, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 31, 2020

Record last verified: 2020-07

Locations

US (1)