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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032238
Recruitment Status : Terminated (The number of anticipated participants was not achieved)
First Posted : January 9, 2014
Results First Posted : August 11, 2017
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
OD-OS GmbH

Tracking Information
First Submitted Date  ICMJE January 8, 2014
First Posted Date  ICMJE January 9, 2014
Results First Submitted Date  ICMJE January 19, 2017
Results First Posted Date  ICMJE August 11, 2017
Last Update Posted Date August 11, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
Percentage of Eyes That Received Retreatment [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
Percentage of Eyes That Received Retreatment [ Time Frame: 6 and 12 months ]
Change History Complete list of historical versions of study NCT02032238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Efficacy of Bevacizumab Combined With Navigated Laser in Patients With Clinically Significant Macula Edema
Official Title  ICMJE Clinical Efficacy of Bevacizumab Combined With Navigated Laser in Patients With Clinically Significant Macula Edema
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
no masking
Primary Purpose: Treatment
Condition  ICMJE Clinically Significant Macular Edema
Intervention  ICMJE Device: laser photocoagulation
Standard bevacizumab Injections will be combined with laser photocoagulation in a pre-defined manner
Study Arms  ICMJE
  • Experimental: laser photocoagulation with bevacizumab
    Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner
    Intervention: Device: laser photocoagulation
  • No Intervention: Bevacizumab, no laser photocoagulation
    patients receive Anti-VEGF injections (Bevacizumab) only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 29, 2015)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2014)
50
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: history of angle-closure glaucoma is not an exclusion criterion).
  • 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
  • Known allergy to any component of the study drug
  • Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
  • Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
  • Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
  • Systemic anti-vascular growth factor (anti-VEGF) or pro-VEGF treatment within 4 months prior to randomization 14
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
  • Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02032238
Other Study ID Numbers  ICMJE CAVNAV-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party OD-OS GmbH
Study Sponsor  ICMJE OD-OS GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ulrike Weber OD-OS
PRS Account OD-OS GmbH
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP