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Clinical Efficacy of Bevacizumab Combined With Navigated Laser in Patients With Clinically Significant Macula Edema | Clinical Trials | Clareo Health

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Clinical Efficacy of Bevacizumab Combined With Navigated Laser in Patients With Clinically Significant Macula Edema

NCT02032238•OD-OS GmbH

View on ClinicalTrials.gov

Summary

Asses efficacy of navigated laser in reducing the number of anti-VEGF injections as a prospective study using Bevacizumab.

Detailed Description

The purpose of this is study is to assess the efficacy of navigated laser treatment in reducing the number of anti-VEGF injections required to maintain visual gain obtained after Bevacizumab compared to Bevacizumab alone in patients with clinically significant macular edema (CSME). This will be prospective, active-controlled study using Bevacizumab (Genentech, South San Francisco CA) for intravitreal injections. Retinal photocoagulation will utilize the Navilas Laser System (OD-OS GmbH, Teltow, Germany), which is an approved indication for this device.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•CSME and Diagnosis of diabetes mellitus
•Able and willing to provide informed consent prior to any study-related procedures
•Central foveal thickness \> 250 microns at baseline
•Best corrected visual acuity between 20/400 and 20/40
•Willing and able to comply with clinic visits and study-related procedures
•U.S. patients will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws

Exclusion Criteria

•\- Macular edema is considered to be due to a cause other than diabetic macular edema.
•An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., macular ischemia, vitreomacular traction, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition).
•An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.)
•Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
•History of treatment for diabetic macular edema at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).
•History of panretinal (scatter) photocoagulation (PRP) within 4 months prior to enrollment.
•History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. 13
•History of YAG capsulotomy performed within 2 months prior to randomization.
•Aphakia.
•Intraocular pressure \>= 25 mmHg.
+13 more criteria

Locations (1)

Eye and Ear Infirmary

New York, New York, United States

Key Dates

Start Date

March 1, 2013

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

August 11, 2017

Enrollment

ACTUAL participants

Conditions

Clinically Significant Macular Edema

Interventions

laser photocoagulation

DEVICE

Anti-VEGF Therapy Versus Dexamethasone Implant for DME

NCT03999125

Clinically Significant Macular Edema Due to Diabetes Mellitus

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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