Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME) (RESPOND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01135914
First received: May 31, 2010
Last updated: October 22, 2014
Last verified: October 2014
Results First Received: March 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetic Macular Edema
Interventions: Drug: ranibizumab
Procedure: Laser

  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
A total of 239 patients were enrolled in the study. An additional 2 patients were enrolled but were removed from the database because consent was not signed in accordance with GCP principles.”

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 treatment arms: Group C - laser photocoagulation per ETDRS guidelines, Group B - ranibizumab intravitreal injections (3 monthly injections during loading phase, and subsequent treatments per protocol-defined criteria), or Group A - combination therapy, where decisions to treat with laser were independent of decisions to treat with ranibizumab.

Reporting Groups
  Description
Combination Therapy Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
Ranibizumab Monotherapy Participants received ranibizumab intravitreal injection therapy only
Laser Monotherapy Participants received Laser photocoagulation therapy only

Participant Flow:   Overall Study
    Combination Therapy     Ranibizumab Monotherapy     Laser Monotherapy  
STARTED     78     80     81  
Intent to Treat (ITT) Population     73     75     72  
Safety Population     73     75     74  
COMPLETED     74     75     59  
NOT COMPLETED     4     5     22  
Withdrawal by Subject                 1                 3                 6  
Lost to Follow-up                 1                 0                 1  
Protocol Violation                 0                 0                 3  
Lack of Efficacy                 2                 1                 10  
Adverse Event                 0                 1                 2  



  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.
The Intent to Treat (ITT) population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from a center were excluded from ITT.

Reporting Groups
  Description
Combination Therapy Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
Ranibizumab Monotherapy Participants received ranibizumab intravitreal injection therapy only
Laser Monotherapy Participants received Laser photocoagulation therapy only
Total Total of all reporting groups

Baseline Measures
    Combination Therapy     Ranibizumab Monotherapy     Laser Monotherapy     Total  
Number of Participants  
[units: participants]
  73     75     72     220  
Age  
[units: years]
Mean ± Standard Deviation
  60.8  ± 10.21     61.5  ± 9.86     62.8  ± 9.44     61.7  ± 9.83  
Gender  
[units: participants]
       
Female     26     33     29     88  
Male     47     42     43     132  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12   [ Time Frame: Baseline and 12 months ]

2.  Secondary:   Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9   [ Time Frame: Baseline, 3, 6 and 9 months ]

3.  Secondary:   Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12   [ Time Frame: Baseline, 3, 6, 9 and 12 months ]

4.  Secondary:   Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline   [ Time Frame: Baseline, 3, 6, 9 and 12 months ]

5.  Secondary:   Percentage of Patients Achieving Gain of Letters From Baseline in BCVA   [ Time Frame: 12 months ]

6.  Secondary:   National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12   [ Time Frame: 12 month ]

7.  Secondary:   EuroQoL (EQ-5D) Utility Score at Month 12   [ Time Frame: 12 month ]

8.  Secondary:   Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12   [ Time Frame: 12 month ]


  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
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  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: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01135914     History of Changes
Other Study ID Numbers: CRFB002DCA05
Study First Received: May 31, 2010
Results First Received: March 19, 2014
Last Updated: October 22, 2014
Health Authority: Canada: Health Canada