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Ranibizumab in Preventing Failure of Ahmed Valve Glaucoma Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00644280
Recruitment Status : Terminated (low recruitment)
First Posted : March 26, 2008
Results First Posted : July 26, 2013
Last Update Posted : July 31, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Shan Lin, University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glaucoma
Intervention Drug: Ranibizumab
Enrollment 11
Recruitment Details Patients were recruited from the University of California, San Francisco (UCSF) Glaucoma Service
Pre-assignment Details  
Arm/Group Title Ranibizumab Usual Care
Hide Arm/Group Description Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
Period Title: Overall Study
Started 6 5
Completed 6 5
Not Completed 0 0
Arm/Group Title Ranibizumab Usual Care Total
Hide Arm/Group Description Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  16.7%
1
  20.0%
2
  18.2%
>=65 years
5
  83.3%
4
  80.0%
9
  81.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
4
  66.7%
3
  60.0%
7
  63.6%
Male
2
  33.3%
2
  40.0%
4
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 5 participants 11 participants
6 5 11
1.Primary Outcome
Title Tube Success at 6 Months
Hide Description Criteria for success at 6 months postoperatively was intraocular pressure (IOP) < 18mmHg without the necessity for adjunctive medication for pressure or IOP < 15mmHg with <=1 adjunctive medication.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ranibizumab Usual Care
Hide Arm/Group Description:
Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: percentage of participants
83 40
2.Secondary Outcome
Title Significant Ocular Adverse Events
Hide Description Participants experiencing significant ocular adverse events, including endophthalmitis and rhegmatogenous retinal detachment
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ranibizumab Usual Care
Hide Arm/Group Description:
Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery
Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
Overall Number of Participants Analyzed 6 5
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ranibizumab Usual Care
Hide Arm/Group Description Ranibizumab (0.5 mg in 0.05 mL) administered intravitreally at 3 time points: 9 days before Ahmed tube insertion for open-angle glaucoma, 1 month post-surgery, and 2 months post-surgery Standard of care Ahmed tube insertion for open-angle glaucoma without injections of Ranibizumab
All-Cause Mortality
Ranibizumab Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ranibizumab Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ranibizumab Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
IOP reduction may be attributable to cataract surgery instead of or in addition to ranibizumab use. Further studies, with larger sample size and longer follow-up, are needed to evaluate safety and potential efficacy of intravitreal ranibizumab.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Shan C. Lin, MD
Organization: University of California San Francisco
Phone: 415-353-2608
Responsible Party: Shan Lin, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00644280     History of Changes
Other Study ID Numbers: LinLucentis
NIH Grant # FVF4191S
First Submitted: March 24, 2008
First Posted: March 26, 2008
Results First Submitted: May 29, 2013
Results First Posted: July 26, 2013
Last Update Posted: July 31, 2013