Using Aflibercept Injection to Treat Blood Vessel Growth Over the Cornea

Conditions

• Corneal Neovascularization

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Subconjunctival aflibercept — DRUG
  subconjunctival aflibercept injection
• Placebo: Standard of care only — OTHER
  Patients will receive standard of care (steroids and cyclosporine) treatment only.

Study Details

The cornea is the clear front part of the eye. Corneal neovascularization, the excessive growth of blood vessels into the cornea, is a sight-threatening condition. Corneal neovascularization is also a well recognized risk factor for corneal graft failure. The current standard of care to prevent graft rejection includes use of topical steroids and medicines that suppress the immune system. These medicines do not address corneal neovascularization. The purpose of the study is to establish the safety and potential efficacy of subconjunctival injections of aflibercept (EYLEA® , marketed by Regeneron) injection in inducing regression of blood vessels growing into the cornea and promoting graft survival. This study is being conducted by Dr. Balamurali Ambati at the Moran Eye Center.

Key Dates

Start date

Jun 30, 2013

Status verified

Oct 2015

Primary completion

Oct 31, 2015

Completion

Oct 31, 2015

Study Design

Enrollment

2 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group A subconjunctival aflibercept
  Patients will receive 2mg (0.05mL) subconjunctival aflibercept injection in addition to standard of care treatment (steroids and cyclosporine). Patients will receive one injection four weeks (+/- 1 week) prior to transplantation. They will receive a second injection at the conclusion of corneal transplantation. Patients may receive as-needed repeat injections (minimum of 30 days in between treatments) for recurrence of corneal neovascularization (defined as \>1.0 mm crossing onto the cornea, past the limbus, or extension of vessels beyond previously documented extent) during the follow-up period.
• Placebo Comparator: Group B: Standard of care only
  Patients will receive standard of care (steroids and cyclosporine) treatment only.

Primary Outcome Measure

Safety defined by incidence and severity of adverse events at week 28 [ Time Frame: Week 28 ]

Locations (1)

Find similar trials in Salt Lake City, UT

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