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Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N) (N)

This study has been completed.
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00996437
First received: October 14, 2009
Last updated: August 25, 2016
Last verified: August 2016
Results First Received: February 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Vitreous Hemorrhage
Proliferative Diabetic Retinopathy
Interventions: Drug: Ranibizumab
Drug: Saline

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ranibizumab Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
Saline Injection Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks

Participant Flow:   Overall Study
    Ranibizumab   Saline Injection
STARTED   125   136 
COMPLETED   120   129 
NOT COMPLETED   5   7 
Death                1                0 
Dropped                2                2 
Missed                2                5 



  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.
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Reporting Groups
  Description
Ranibizumab Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
Saline Injection Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
Total Total of all reporting groups

Baseline Measures
   Ranibizumab   Saline Injection   Total 
Overall Participants Analyzed 
[Units: Participants]
 125   136   261 
Age, Customized 
[Units: Years]
Median (Inter-Quartile Range)
 61 
 (50 to 67) 
 58 
 (49 to 64) 
 59 
 (50 to 66) 
Gender 
[Units: Participants]
     
Female   65   70   135 
Male   60   66   126 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   67   70   137 
African-American   20   22   42 
Hispanic or Latino   32   34   66 
Asian   1   4   5 
Native Hawaiian/Other Pacific Islander   2   1   3 
American Indian/Alaskan Native   0   2   2 
More than one race   2   1   3 
Unknown/not reported   1   2   3 
Diabetes Type 
[Units: Participants]
     
Type1   21   31   52 
Type 2   101   99   200 
Uncertain   3   6   9 
Duration of Diabetes (years) 
[Units: Number]
Median (Inter-Quartile Range)
 19 
 (12 to 28) 
 21 
 (16 to 27) 
 20 
 (13 to 27) 
Hemoglobin A1c 
[Units: Percentage]
Median (Inter-Quartile Range)
 7.7 
 (6.7 to 8.7) 
 8.0 
 (6.9 to 9.3) 
 7.9 
 (6.8 to 9.0) 
Pre-Existing Cardiovascular Conditions 
[Units: Participants]
     
Yes   44   60   104 
No   81   76   157 
Pre-Existing Hypertension 
[Units: Participants]
     
Yes   105   117   222 
No   20   19   39 
Prior panretinal photocoagulation 
[Units: Participants]
     
Yes   62   78   140 
No   63   58   121 
Prior Treatment for Diabetic Macular Edema 
[Units: Participants]
     
Yes   53   57   110 
No   72   79   151 
Prior treatment with anti-vascular endothelial growth factor drug for diabetic macular edema 
[Units: Participants]
     
Yes   10   18   28 
No   115   118   233 
Lens Status (on clinical exam) 
[Units: Participants]
     
Phakic   97   98   195 
Posterior Chamber Intraocular Lens   28   38   66 
Optical coherence tomography signal strength [1] 
[Units: Participants]
     
=0   74   96   170 
> 0   50   38   88 
Missing/not available   1   2   3 
[1] The Ns represent the total number of available baseline optical coherence tomography signal strengths data. Optical Coherence Tomography Signal strength is measured on a scale of 0-10 with 10 being the maximum signal strength, a greater signal strength indicates a better image.
Ultrasound completed to assess eligibility 
[Units: Participants]
     
Yes   62   62   124 
No   63   74   137 
Duration of vitreous hemorrhage since first documented on clinical exam 
[Units: Participants]
     
< 1month   66   75   141 
1-3 months   41   39   80 
4-6 months   7   11   18 
> 6 months   11   11   22 
Median Electronic-Early Treatment Diabetic Retinopathy Visual Acuity (letter score) [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
 34 
 (0 to 61) 
 28 
 (0 to 59) 
 31 
 (0 to 61) 
[1] Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best
Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score [1] 
[Units: Participants]
     
> 69 letter score - (20/40 or better)   20   21   41 
68 to 49 letter score - (20/50 to 20/100)   32   19   51 
48 to 24 letter score - (20/125 to 20/320)   18   37   55 
23 to 1 letter score - (20/400 to 20/800-3)   19   18   37 
Counting fingers only   12   15   27 
Hand motion only   19   20   39 
Light perception only   5   6   11 
No light perception   0   0   0 
[1] Visual Acuity Electronic Early Treatment Study (E-ETDRS) visual acuity test (Letter Score [snellen equivalent]). Letter score and its snellen equivalent (categorical) are reported. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Intraocular Pressure 
[Units: Mm Hg]
Median (Inter-Quartile Range)
 15 
 (12 to 17) 
 14 
 (12 to 17) 
 15 
 (12 to 17) 
Anti-platelet aggregation and anti-coagulant drugs [1] 
[Units: Participants]
     
Aspirin   50   57   107 
Other anti-platelet aggregation drugs   19   21   40 
Anti-coagulants   7   6   13 
NSAIDs   15   15   30 
Not Available   34   37   71 
[1] The Ns represent concomitant medications reported throughout the study duration. Please notice that these might not be equal to the number of participants enrolled.


  Outcome Measures
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1.  Primary:   Treatment or "Failure" Defined as Vitrectomy   [ Time Frame: within 112 days of randomization ]

2.  Primary:   Safety (Injected-related, Ocular Drug-related and Systemic Drug-related)   [ Time Frame: Baseline to 16 weeks ]

3.  Secondary:   Ability to Complete Panretinal Photocoagulation (PRP) in the Absence of Vitrectomy   [ Time Frame: within 112 days of randomization ]

4.  Secondary:   Extent of Vitreous Hemorrhage Measured by Optical Coherence Tomography Signal Strength   [ Time Frame: 4, 8 and 12 weeks ]

5.  Secondary:   Visual Acuity Adjusted for the Baseline Acuity Regardless of Vitrectomy Status   [ Time Frame: 4, 8 and 12 weeks ]

6.  Secondary:   Visual Acuity Better Than 20/40 and no Vitrectomy Prior to the Visit   [ Time Frame: 4, 8 and 12 weeks ]

7.  Secondary:   Severe Visual Acuity Loss (Defined as <20/200)   [ Time Frame: 4,8 and 12 weeks ]

8.  Secondary:   Very Severe Visual Acuity Loss (Defined as <20/800)   [ Time Frame: 4,8 and 12 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Adam R. Glassman
Organization: Diabetic Retinopathy Clinical Research Network
phone: 813-975-8761
e-mail: drcrstat4@jaeb.org


Publications of Results:
Other Publications:

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00996437     History of Changes
Other Study ID Numbers: NEI-151
U10EY018817-03 ( US NIH Grant/Contract Award Number )
U10EY014231-09 ( US NIH Grant/Contract Award Number )
Study First Received: October 14, 2009
Results First Received: February 19, 2013
Last Updated: August 25, 2016
Health Authority: United States: Food and Drug Administration