Does Adding Bevacizumab Therapy in Glaucoma Surgery Improve the Success of Needle Bleb Revisions? (Avastin)
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|ClinicalTrials.gov Identifier: NCT00853073|
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : March 12, 2015
Last Update Posted : July 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: bevacizumab Other: balanced salt solution||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does a New Add on (or Adjunctive) Therapy Used in Glaucoma Surgery Improve the Success of Needle Bleb Revisions?|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Active Comparator: Bevacizumab
subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure
Other Name: Avastin
Placebo Comparator: balanced salt solution
patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Other: balanced salt solution
0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure
- Intraocular Pressure (IOP) [ Time Frame: 6 months ]mmHg (millimeters of mercury)
- Number of Participants With Surgical Success [ Time Frame: 6 months ]Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853073
|United States, Pennsylvania|
|Wills Eye Institute, Glaucoma Service|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Marlene R Moster, MD||Wills Eye|