Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

University of New Mexico (UNM)

Status and phase: Completed; Phase 1

Conditions: Pterygium

Treatments: Drug: Ranibizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01169909

09-117

Details and patient eligibility

About

Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in pterygium, a neovascular disorder of the ocular surface.

Full description

Ptergyia are chronic fibrovascular lesions of the ocular surface. This study is designed to look for a signal of efficacy when the lesions are in a phase of active vascular growth. This phase is most often caught in a newly recurring pterygia post-operatively.

Patients identified with actively growing lesions, will be offered local injections directly beneath the lesions. They will be examined for any adverse side effects and regression of the lesion.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Patients with actively growing pterygia, either surgical recurrences, or non-surgical primary lesions.

Exclusion criteria

• Pregnancy
• History of CVA
• Monocular patients
• Minors

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Ranibizumab treatment

Experimental group

Description:

Patients will receive a sub-tenons injection of Ranibizumab 0.5mg, to be repeated twice with 30 day intervals between each dose.

Treatment:

Drug: Ranibizumab