Phase 2 N=30 Randomized Triple-blind Treatment

Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival

Corneal Neovascularization · Corneal Graft Failure

Bottom Line

View on ClinicalTrials.gov: NCT01072357 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

May 2017

Primary outcome: Primary: Number of Participants With Graft Failure at Week 39 and 52 — 0; 1; 1; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Avastin® (bevacizumab) (Drug); 0.9% NaCl & Refresh Liquigel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Reza Dana, MD
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Graft Failure at Week 39 and 52	0; 1; 1; 1	—
SECONDARY Endothelial Cell Density	1814.25; 2249.83; 1432.50; 1926.67	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Age > 18 years
Patient or legally authorized representative willing and able to provide written informed consent
Willing and able to comply with study assessments for the full duration of the study
High-risk characteristics for penetrating keratoplasty: Either presence of 1.) Corneal NV in one or more quadrants (≥ 3 clock hours NV ≥ 2mm from the limbus) OR 2.) Extension of corneal NV to graft-host junction in a previous failed graft
In generally good stable overall health

Exclusion Criteria

History of Stevens-Johnson syndrome or ocular pemphigoid
Ocular or periocular malignancy
Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
Uncontrolled glaucoma
Currently on dialysis
Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry
Concurrent use of systemic anti-VEGF agents
Change in topical corticosteroid regimen within 14 days of transplantation
Use of systemic immunosuppressive for indication other than corneal graft rejection
Pregnancy (positive pregnancy test) or lactating
Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
Uncontrolled hypertension defined as systolic blood pressure (BP) ≥150 or diastolic BP ≥90 mmHg
History of thromboembolic event within 12 months prior to study entry
Participation in another simultaneous medical investigation or trial

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Data sourced from ClinicalTrials.gov (NCT01072357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.