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Trial record 64 of 81 for:    CRVO - Central Retinal Vein Occlusion

Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab (RAVEN)

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ClinicalTrials.gov Identifier: NCT01471691
Recruitment Status : Completed
First Posted : November 16, 2011
Results First Posted : April 29, 2015
Last Update Posted : April 29, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hanscom, Thomas, M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Branch Retinal Vein Occlusion
Central Retinal Vein Occlusion
Macular Edema
Interventions Drug: ranibizumab 0.5mg
Drug: ranibizumab 1.0mg
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intravitreal Ranibizumab 0.5mg Intravitreal Ranibizumab 1.0mg
Hide Arm/Group Description ranibizumab 0.5mg: Standard dose Patients were given six months of monthly treatment with the standard 0.5mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria. ranibizumab 1.0mg: High dose Patients were given six months of monthly treatment with the 1.0mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
Period Title: Overall Study
Started 8 6
Completed 8 5
Not Completed 0 1
Reason Not Completed
Lack of Efficacy             0             1
Arm/Group Title Intravitreal Ranibizumab 0.5mg Intravitreal Ranibizumab 1.0mg Total
Hide Arm/Group Description ranibizumab 0.5mg: Standard dose ranibizumab 1.0mg: High dose Total of all reporting groups
Overall Number of Baseline Participants 8 6 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 6 participants 14 participants
73  (5.0) 78  (5.0) 75  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 6 participants 14 participants
Female
7
  87.5%
2
  33.3%
9
  64.3%
Male
1
  12.5%
4
  66.7%
5
  35.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 6 participants 14 participants
8 6 14
1.Primary Outcome
Title Mean Change From Baseline BCVA
Hide Description Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.
Time Frame Baseline to month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravitreal Ranibizumab 0.5mg Intravitreal Ranibizumab 1.0mg
Hide Arm/Group Description:
ranibizumab 0.5mg: Standard dose
ranibizumab 1.0mg: High dose
Overall Number of Participants Analyzed 8 5
Mean (Standard Deviation)
Unit of Measure: Letters (ETDRS chart)
14  (10) 5  (6)
2.Secondary Outcome
Title Mean Change From Baseline in Center Point Thickness
Hide Description [Not Specified]
Time Frame months 1-12
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change in Mean Best Corrected Visual Acuity From Baseline
Hide Description [Not Specified]
Time Frame months 1-12
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Percentage of Patients With CFT Less Than 300um
Hide Description [Not Specified]
Time Frame Month 6 and 12
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Excess Foveal Thickness
Hide Description [Not Specified]
Time Frame Month 6 and 12
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Total Number of Ranibizumab Injections
Hide Description [Not Specified]
Time Frame month 12
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravitreal Ranibizumab 0.5mg Intravitreal Ranibizumab 1.0mg
Hide Arm/Group Description ranibizumab 0.5mg: Standard dose ranibizumab 1.0mg: High dose
All-Cause Mortality
Intravitreal Ranibizumab 0.5mg Intravitreal Ranibizumab 1.0mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intravitreal Ranibizumab 0.5mg Intravitreal Ranibizumab 1.0mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/8 (25.00%)      0/6 (0.00%)    
Ear and labyrinth disorders     
Ruptured Retinal Macroaneurysm  1/8 (12.50%)  1 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast Cancer [1]  1/8 (12.50%)  1 0/6 (0.00%)  0
[1]
Patient developed breast cancer during trial. It was treated by her oncologist. Not felt to be secondary to Ranibizumab.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravitreal Ranibizumab 0.5mg Intravitreal Ranibizumab 1.0mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/6 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Thomas O'Hearn MD
Organization: Thomas Hanscom AMC
Phone: 310-829-3303
Responsible Party: Hanscom, Thomas, M.D.
ClinicalTrials.gov Identifier: NCT01471691     History of Changes
Other Study ID Numbers: ML27847
First Submitted: November 9, 2011
First Posted: November 16, 2011
Results First Submitted: March 17, 2015
Results First Posted: April 29, 2015
Last Update Posted: April 29, 2015