Back to resultsLaser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
PASCAL Endpoint Management (EpM) laser treatment
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring 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
Eligibility 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.
Sites / Locations
- San Francisco General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IVB + laser
IVB only
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Retinal thickness
Change in retinal thickness on SD-OCT from baseline to 12 months.
Secondary Outcome Measures
Visual Acuity
Change in Snellen visual acuity from baseline to 12 months.
Number of injections of bevacizumab needed
Full Information
NCT ID
NCT02229175
First Posted
August 14, 2014
Last Updated
July 29, 2020
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT02229175
Brief Title
Laser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema
Official Title
Comparison of Subvisible Retinal Laser Therapy With Intravitreal Bevacizumab in Treatment of Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study not feasible with current resources.
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IVB + laser
Arm Type
Experimental
Arm Description
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.
Arm Title
IVB only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
intravitreal injections of antibodies inhibiting vascular endothelial growth factor
Intervention Type
Device
Intervention Name(s)
PASCAL Endpoint Management (EpM) laser treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retinal thickness
Description
Change in retinal thickness on SD-OCT from baseline to 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
Change in Snellen visual acuity from baseline to 12 months.
Time Frame
12 months
Title
Number of injections of bevacizumab needed
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Stewart, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Chao, MD, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Psaras, BA
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Director
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Laser vs Bevacizumab Injection Alone in Treatment of Diabetic Macular Edema
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