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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Diabetic Retinopathy Clinical Research Network
ClinicalTrials.gov Identifier:
NCT00996437
First received: October 14, 2009
Last updated: May 15, 2013
Last verified: May 2013
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
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
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  
Number of Participants  
[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  
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) [2]
[units: Units on a scale]
Median ( Inter-Quartile Range )
  34  
  ( 0 to 61 )  
  28  
  ( 0 to 59 )  
  31  
  ( 0 to 61 )  
Electronic Early Treatment Diabetic Retinopathy Visual Acuity Score [3]
[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  
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 [4]
[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 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.
[2] 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
[3] 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.
[4] 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


  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.


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.  


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


No publications provided by Diabetic Retinopathy Clinical Research Network

Publications automatically indexed to this study:

Responsible Party: Diabetic Retinopathy Clinical Research Network
ClinicalTrials.gov Identifier: NCT00996437     History of Changes
Other Study ID Numbers: NEI-151, U10EY018817-03, U10EY014231-09
Study First Received: October 14, 2009
Results First Received: February 19, 2013
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration