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

NCT02032238 | Terminated Results

• 1 other identifier: CAVNAV-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Clinically Significant Macular Edema

Outcome Measures

Primary Outcomes (1)

• Percentage of Eyes That Received Retreatment

  12 months

Study Arms (2)

laser photocoagulation with bevacizumab

EXPERIMENTAL

Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner

Device: laser photocoagulation

Bevacizumab, no laser photocoagulation

NO INTERVENTION

patients receive Anti-VEGF injections (Bevacizumab) only

Interventions

laser photocoagulation DEVICE

Standard bevacizumab Injections will be combined with laser photocoagulation in a pre-defined manner

laser photocoagulation with bevacizumab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \- 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.
• History of steroid-induced intraocular pressure (IOP) elevation that required IOP-lowering treatment.
• Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
• Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control)
• Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry

Sponsors & Collaborators

• OD-OS GmbH: lead

Study Sites (1)

Eye and Ear Infirmary

New York, New York, 10009, United States

Location

Results Point of Contact

• Title: Ulrike Weber
• Organization: OD-OS GmbH

ulrike.weber@od-os.com

+49 332831282

Study Officials

• Ulrike Weber

  OD-OS

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: March 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 11, 2017
• Results First Posted: August 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)