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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Clinically Significant Macular Edema
Intervention Device: laser photocoagulation
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Laser Photocoagulation With Bevacizumab Bevacizumab, no Laser Photocoagulation
Hide Arm/Group Description Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner patients receive Anti-VEGF injections (Bevacizumab) only
Period Title: Overall Study
Started 12 0 [1]
Completed 10 0
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             2             0
[1]
Study Terminated due to slow enrollment, no subjects enrolled in this study arm
Arm/Group Title Combination With Navigated Laser Monotherapy Total
Hide Arm/Group Description

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

Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner

Anti-VEGF Injections: Monotherapy

patients receive Anti-VEGF Monotherapy

Anti-VEGF Injections: Monotherapy

Total of all reporting groups
Overall Number of Baseline Participants 12 0 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 0 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  50.0%
6
  50.0%
>=65 years
6
  50.0%
6
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 0 participants 12 participants
Female
4
  33.3%
4
  33.3%
Male
8
  66.7%
8
  66.7%
1.Primary Outcome
Title Percentage of Eyes That Received Retreatment
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Combination With Navigated Laser Monotherapy
Hide Arm/Group Description:

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

Navigated laser: Standard Anti-VEGF Injections will be combined with Navigated laser in a pre-defined manner

Anti-VEGF Injections: Monotherapy

patients receive Anti-VEGF Monotherapy

Anti-VEGF Injections: Monotherapy

Overall Number of Participants Analyzed 10 0
Measure Type: Number
Unit of Measure: Percentage of eyes that received retreat
55.56
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Laser Photocoagulation With Bevacizumab Bevacizumab, no Laser Photocoagulation
Hide Arm/Group Description Combining laser photocoagulation and Anti-VEGF Injections in a pre-defined manner patients receive Anti-VEGF injections (Bevacizumab) only
All-Cause Mortality
Laser Photocoagulation With Bevacizumab Bevacizumab, no Laser Photocoagulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/0 
Hide Serious Adverse Events
Laser Photocoagulation With Bevacizumab Bevacizumab, no Laser Photocoagulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Laser Photocoagulation With Bevacizumab Bevacizumab, no Laser Photocoagulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ulrike Weber
Organization: OD-OS GmbH
Phone: +49 332831282 ext 100
EMail: ulrike.weber@od-os.com
Layout table for additonal information
Responsible Party: OD-OS GmbH
ClinicalTrials.gov Identifier: NCT02032238    
Other Study ID Numbers: CAVNAV-2
First Submitted: January 8, 2014
First Posted: January 9, 2014
Results First Submitted: January 19, 2017
Results First Posted: August 11, 2017
Last Update Posted: August 11, 2017