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Safety and Efficacy of Ranibizumab in Diabetic Macular Edema (RELATION)

This study has been terminated.
(European drug approval.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01131585
First received: May 25, 2010
Last updated: August 20, 2012
Last verified: August 2012
Results First Received: July 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Visual Impairment Due to Diabetic Macular Edema
Interventions: Procedure: Active laser photocoagulation
Drug: Sham injections
Drug: Ranibizumab 0.5 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants did not complete study due to early termination. Study was terminated because of drug approval.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active Laser Photocoagulation and Ranibizumab

Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Active Laser Photocoagulation and Sham Injection

Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.


Participant Flow:   Overall Study
    Active Laser Photocoagulation and Ranibizumab     Active Laser Photocoagulation and Sham Injection  
STARTED     85     43  
COMPLETED     0     0  
NOT COMPLETED     85     43  
Adverse Event                 0                 2  
Abnormal laboratory value                 1                 0  
Unsatisfactory therapeutic effect                 0                 3  
Protocol Violation                 2                 1  
Withdrawal by Subject                 3                 3  
Lost to Follow-up                 0                 1  
Administrative problems                 1                 1  
Study termination                 78                 32  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active Laser Photocoagulation and Ranibizumab

Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Active Laser Photocoagulation and Sham Injection

Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.

Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.

Total Total of all reporting groups

Baseline Measures
    Active Laser Photocoagulation and Ranibizumab     Active Laser Photocoagulation and Sham Injection     Total  
Number of Participants  
[units: participants]
  85     43     128  
Age  
[units: years]
Mean ± Standard Deviation
     
>=18 years     63.5  ± 9.3     63.5  ± 10.5     63.5  ± 9.7  
Gender  
[units: participants]
     
Female     32     16     48  
Male     53     27     80  



  Outcome Measures

1.  Primary:   Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early study termination due to European drug approval.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 41 61 324 1111


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01131585     History of Changes
Other Study ID Numbers: CRFB002DDE13, 2010-018852-29
Study First Received: May 25, 2010
Results First Received: July 12, 2012
Last Updated: August 20, 2012
Health Authority: Germany: Paul-Ehrlich-Institut