A Multi-Center Study of the Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival
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|ClinicalTrials.gov Identifier: NCT01996826|
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Corneal Neovascularization Corneal Graft Failure||Drug: Avastin® (bevacizumab) Drug: 0.9% NaCl & Refresh Liquigel||Phase 1 Phase 2|
The purpose of this study is to test the effectiveness of a drug, bevacizumab (Avastin), in preventing blood vessels that often occur after a corneal transplantation which are considered at "high-risk" for rejection. In many cases these blood vessels lead to the graft rejection and eventual failure of the corneal transplant. It is hoped that this treatment will increase the chances of corneal graft survival.
The medication used in this study is called bevacizumab or Avastin (Genentech, Inc). It works by inhibiting the action of a molecule called vascular endothelial growth factor (VEGF). VEGF is a substance molecule that binds to certain cells to stimulate new blood vessel formation. When VEGF is bound to the drug, it cannot stimulate the formation and growth of new blood vessels. Growth of blood vessels into the cornea is a complication which can worsen the prognosis of your corneal transplant and put the transplant at a higher risk for rejection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-Center Study of the Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival|
|Actual Study Start Date :||April 2014|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||April 2019|
Active Comparator: Avastin® (bevacizumab)
Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
Drug: Avastin® (bevacizumab)
One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.
Placebo Comparator: 0.9% NaCl & Refresh Liquigel
Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% NaCl. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.
The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.
Drug: 0.9% NaCl & Refresh Liquigel
One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks.
- Endothelial Rejection Rate [ Time Frame: 12 Months ]
- Incidence of Ocular Adverse Events [ Time Frame: 12 months ]Incidence and severity of ocular adverse events during the study (based on ophthalmic examination and subject self-reporting).
- Incidence of Systemic Adverse Events [ Time Frame: 12 Months ]Incidence and severity of systemic adverse events during the study (based on physical examination, subject self-reporting, and changes in vital sign).
- Time from Surgery to Any Rejection Episode [ Time Frame: 16, 26, and 52 weeks post-op ]Time from surgery to occurrence of any rejection episode (endothelial, epithelial, subepithelial)
- Time from Surgery to Graft Failure [ Time Frame: 12 Months ]Time from surgery to overall graft failure (regardless of cause)
- Incidence of Delayed Epithelial Healing [ Time Frame: 7 days post-op ]
- Endothelial Cell Density [ Time Frame: 52 Weeks ]Endothelial Cell Density (Compared at Weeks 26 & 52)
- Central Corneal Thickness [ Time Frame: 52 Weeks ]Central corneal thickness at Weeks 16, 26, and 52
- Frequency of Primary Graft Failure [ Time Frame: 52 Weeks ]
- Change in Corneal Neovascularization Metrics [ Time Frame: 52 weeks ]
Corneal NV Metrics Neovascular Area (NA): measuring the area of the corneal vessels themselves
Vessel Caliber (VC): measuring the mean diameter of the corneal vessels
Invasion Area (IA): measuring the fraction of corneal area in which vessels are present
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): NCT01996826
|United States, Florida|
|Bascom Palmer Eye Institute|
|Miami, Florida, United States, 33136|
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary|
|Boston, Massachusetts, United States, 02114|
|United States, New York|
|New York Presbyterian Hospital|
|New York, New York, United States, 10065|
|Principal Investigator:||Reza Dana, MD, MPH, MSc||Massachusetts Eye and Ear Infirmary|