A Phase 1/2 interventional study of Avastin® (bevacizumab) and 0.9% NaCl & Refresh Liquigel in Corneal Neovascularization and Corneal Graft Failure, sponsored by Reza Dana, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-15.
Sponsored by Reza Dana, MD · Phase 1/2, Interventional, and Treatment
The leading risk factor for corneal transplant rejection is abnormal blood vessel growth of the host bed. Vascular endothelial growth factor (VEGF) is thought to be a mediator of this corneal neovascularization (NV), therefore we would like to test the safety and efficacy of local VEGF blockade in the promotion of graft survival in high risk corneal transplants.
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.
27 studies on the registry are indexed under Corneal Neovascularization; 4 are open to participants now.
This study's enrollment of 30 is above the median of 24 across 22 interventional studies indexed under Corneal Neovascularization.
Browse Corneal Neovascularization studies →Reza Dana, MD is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (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)
Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (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 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.
Also known as: Avastin, bevacizumab
One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks
Also known as: Sodium Chloride, Refresh Liquigel, NaCL
Number of Participants With Graft Failure at Week 39 and 52
Time from surgery to overall graft failure (regardless of cause). Graft failure was monitored throughout the entire study, but only the time points at which graft failure occurred are reported below.
Time frame: 12 months
Endothelial Cell Density
Endothelial Cell Density (Assessed at Weeks 26 \& 52). Measure of the number of cells present within the endothelium that are responsible for providing the cornea with nourishment.
Time frame: 52 Weeks
| Milestone | Avastin® (Bevacizumab) | 0.9% NaCl & Refresh Liquigel |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 14 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
Time from surgery to overall graft failure (regardless of cause). Graft failure was monitored throughout the entire study, but only the time points at which graft failure occurred are reported below.
| Participants | Avastin® (Bevacizumab) | 0.9% NaCl & Refresh Liquigel |
|---|---|---|
| 39 Week Time Point | 0 | 1 |
| 52 Week Time Point | 1 | 1 |
Endothelial Cell Density (Assessed at Weeks 26 \& 52). Measure of the number of cells present within the endothelium that are responsible for providing the cornea with nourishment.
| Number of cells per millimeters squared | Avastin® (Bevacizumab) | 0.9% NaCl & Refresh Liquigel |
|---|---|---|
| Week 26 Time Point | 1814.25 ± 729.72 | 2249.83 ± 891.25 |
| Week 52 Time Point | 1432.50 ± 696.61 | 1926.67 ± 948.03 |
Collected over 52 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Avastin® (Bevacizumab) | 0/15 (0%) | 1/15 (6.7%) | 13/15 (86.7%) |
| 0.9% NaCl & Refresh Liquigel | 0/15 (0%) | 1/15 (6.7%) | 13/15 (86.7%) |
| Event | Avastin® (Bevacizumab) | 0.9% NaCl & Refresh Liquigel |
|---|---|---|
| StrokeNervous system disorders | 0/15 | 1/15 |
| Congestive Heart FailureCardiac disorders | 1/15 | 0/15 |
| Event | Avastin® (Bevacizumab) | 0.9% NaCl & Refresh Liquigel |
|---|---|---|
| TearingEye disorders | 6/15 | 4/15 |
| Ocular PainEye disorders | 6/15 | 4/15 |
| Foreign Body SensationEye disorders | 5/15 | 4/15 |
| Blurry VisionEye disorders | 5/15 | 3/15 |
| PhotophobiaEye disorders | 4/15 | 1/15 |
| Age, Continuous(years) | Avastin® (Bevacizumab) | 0.9% NaCl & Refresh Liquigel | Total |
|---|---|---|---|
| Mean | 71.3 ± 17.0 | 63.0 ± 13.0 | 67.2 ± 15.5 |
| Sex: Female, Male(Participants) | Avastin® (Bevacizumab) | 0.9% NaCl & Refresh Liquigel | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 7 | 6 | 13 |
| Race/Ethnicity, Customized(Participants) | Avastin® (Bevacizumab) | 0.9% NaCl & Refresh Liquigel | Total |
|---|---|---|---|
| White | 8 | 10 | 18 |
| Hispanic | 2 | 1 | 3 |
| African American | 4 | 3 | 7 |
| Asian | 1 | 0 | 1 |
Plan to share: No
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Reza Dana, MD