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Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion (BRIGHTER)

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ClinicalTrials.gov Identifier: NCT01599650
Recruitment Status : Completed
First Posted : May 16, 2012
Results First Posted : November 10, 2016
Last Update Posted : November 10, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Branch Retinal Vein Occlusion
Interventions: Drug: Ranibizumab
Procedure: Laser

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
1-ranibizumab Monotherapy laser therapy + Ranibizumab 0.5 mg
2-ranibizumab With Laser Ranibizumab 0.5 mg + laser
3-laser Monotherapy after 6 months, laser patients could be treated with ranibizumab

Participant Flow:   Overall Study
    1-ranibizumab Monotherapy   2-ranibizumab With Laser   3-laser Monotherapy
STARTED   183   180   92 
Completed 6 Mos   174   170   80 
COMPLETED   161   154   65 
NOT COMPLETED   22   26   27 
Administrative issue                1                0                1 
Physician Decision                2                0                7 
Protocol Violation                0                3                0 
Death                2                1                2 
Lost to Follow-up                3                3                3 
Withdrawal by Subject                11                11                10 
Adverse Event                3                8                4 



  Baseline Characteristics

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
1-ranibizumab Monotherapy laser therapy + Ranibizumab 0.5 mg
2-ranibizumab With Laser Ranibizumab 0.5 mg + laser
3-laser Monotherapy after 6 months, laser patients could be treated with ranibizumab
Total Total of all reporting groups

Baseline Measures
   1-ranibizumab Monotherapy   2-ranibizumab With Laser   3-laser Monotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 183   180   92   455 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.7  (10.34)   67.3  (10.41)   67.7  (9.67)   66.3  (10.30) 
Gender 
[Units: Participants]
       
Female   90   84   55   229 
Male   93   96   37   226 


  Outcome Measures

1.  Primary:   Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)   [ Time Frame: Baseline, 6 Months ]

2.  Secondary:   The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline   [ Time Frame: Baseline, 24 Months ]

3.  Secondary:   Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group   [ Time Frame: Day 1 through Month 23 ]

4.  Secondary:   Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6   [ Time Frame: From Baseline through Month 6 ]

5.  Secondary:   The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24   [ Time Frame: Baseline, Month 12 and Month 24 ]

6.  Secondary:   The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit   [ Time Frame: Baseline, Month 6 and Month 24 ]

7.  Secondary:   Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye   [ Time Frame: Month 6 ]

8.  Secondary:   Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye   [ Time Frame: Month 24 ]

9.  Secondary:   The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm   [ Time Frame: Month 12 and Month 24 ]

10.  Secondary:   The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline   [ Time Frame: Months 6 and 24 ]

11.  Secondary:   BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm   [ Time Frame: Month 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01599650     History of Changes
Other Study ID Numbers: CRFB002E2402
2011-002859-34 ( EudraCT Number )
First Submitted: May 2, 2012
First Posted: May 16, 2012
Results First Submitted: May 26, 2016
Results First Posted: November 10, 2016
Last Update Posted: November 10, 2016