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Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01580020
First received: April 16, 2012
Last updated: April 11, 2016
Last verified: April 2016
Results First Received: September 28, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Retinal Vein Occlusion
Interventions: Biological: RFB002
Drug: Dexamethasone

  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 140 patients with (BRVO) completed the core study CRFB002EDE17, and 127 patients with (CRVO) completed the core study CRFB002EDE18. 92 patients with BRVO and 83 patients with CRVO were enrolled into the extension study. A total of 175 patients (113 in the ranibizumab group and 62 in the dexamethasone group) were enrolled

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. LOCF=last observation carried forward

Reporting Groups
  Description
Ranibizumab (BRVO) Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Dexamethasone (BRVO) A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Ranibizumab (CRVO) Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally
Dexamethasone (CRVO) A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.

Participant Flow:   Overall Study
    Ranibizumab (BRVO)     Dexamethasone (BRVO)     Ranibizumab (CRVO)     Dexamethasone (CRVO)  
STARTED     52     40     61     22  
COMPLETED     51     33     57     20  
NOT COMPLETED     1     7     4     2  
Lack of Efficacy                 0                 5                 0                 1  
Withdrawal by Subject                 0                 1                 1                 0  
Adverse Event                 1                 1                 1                 1  
Administrative Problems                 0                 0                 1                 0  
Lost to Follow-up                 0                 0                 1                 0  



  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
Ranibizumab Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Dexamethasone A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
Total Total of all reporting groups

Baseline Measures
    Ranibizumab     Dexamethasone     Total  
Number of Participants  
[units: participants]
  113     62     175  
Age  
[units: Years]
Mean (Standard Deviation)
  65.6  (9.9)     63.3  (10.3)     64.8  (10.1)  
Gender  
[units: Participants]
     
Female     64     26     90  
Male     49     36     85  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 6 months ]

2.  Secondary:   Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group   [ Time Frame: Baseline, 6 months and 12 months ]

3.  Secondary:   Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline   [ Time Frame: 12 month ]

4.  Secondary:   Change in Central Subfield Thickness (CSRT) From Baseline to Month 12   [ Time Frame: Baseline , Month 12 ]

5.  Secondary:   Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12   [ Time Frame: Baseline, Month 12 ]

6.  Secondary:   Change in Mean Visual Function Questionnaire (VFQ-25)   [ Time Frame: Baseline, 12 months ]

7.  Secondary:   Change in SF-36 Summary Scores   [ Time Frame: Baseline, month 12 ]

8.  Secondary:   Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores   [ Time Frame: Baseline, month 12 ]

9.  Secondary:   Time to the First Retreatment of Both Treatment Arms   [ Time Frame: 6 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
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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
e-mail: trialandresults.registries@novartis.com



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01580020     History of Changes
Other Study ID Numbers: CRFB002EDE20
2011-005045-13 ( EudraCT Number )
Study First Received: April 16, 2012
Results First Received: September 28, 2015
Last Updated: April 11, 2016
Health Authority: Germany: Paul-Ehrlich-Institut