Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study

Phase 3

• Conditions: Glaucoma, Neovascular; Ranibizumab
• Interventions: Drug: Intravitreal ranibizumab

• Registration Number: NCT02914626
• Lead Sponsor: LEANDRO CABRAL ZACHARIAS

Brief Summary

Neovascular glaucoma is a potentially blinding condition characterized by the growth of newvessels at the anterior part of the eye. This growth is driven by the overexpression of a protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order to decrease VEGF formation. The investigators postulate that the use of anti-VEGF intravitreal injections may accelerate recovery and decrease the need of surgery in cases of neovascular glaucoma.

Detailed Description

This is a prospective, randomized controlled study that aims to evaluate the efficacy of ranibizumab (Lucentis®) as an adjunct in the treatment of patients with neovascular glaucoma.

28 patients with neovascular glaucoma (14 in the study group and 14 in the control standard of care group) will be recruited at a single center- University of Sao Paulo Medical School General Hospital. A complete ophthalmologic exam will be carried out, including the obtention of an informed consent for eligible patients willing to participate on the study.

Patients will be randomly assigned to either standard of care- retinal laser photocoagulation and clinical management of intraocular pressure with drops, or standard of care plus intravitreal ranibizumab injections. Two injections will be performed 30 days apart. The patients will be followed for 6 months.

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-23
• Last Update Submitted: 2016-09-24
• Study First Posted: 2016-09-26
• Last Update Posted: 2016-09-27
• Study Start: 2016-10
• Primary Completion: 2017-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• IOP greater than 24 mmHg
• Iris or anterior chamber neovascularization
• At least 120 degrees of opened anterior chamber angle

Exclusion Criteria

• Visual acuity worse than counting fingers in the fellow eye
• No light perception in the treated eye
• Any ocular infectious disease
• Use of systemic steroids
• Lack of media transparency precluding laser photocoagulation
• Thromboembolic disease
• Known hypersensitivity to ranibizumab
• Female participants at childbearing age not using oral contraceptives
• Use of intravitreal anti-VEGF over the last 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Intravitreal ranibizumab	Standard of care therapy plus intravitreal ranibizumab injections
Control	Intravitreal ranibizumab	Standard of care therapy

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	6 months

Secondary Outcome Measures

Name	Time	Method
Need for IOP control surgery	6 months
Anterior segment neovascularization	6 months
Best corrected visual acuity	6 months
Number of drugs needed for IOP control	6 months