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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma, Neovascular, Ranibizumab

Intervention / Treatment
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* Drug: Intravitreal ranibizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranibizumab<br>Standard of care therapy plus intravitreal ranibizumab injections | Drug: Intravitreal ranibizumab<br>* Intravitreal ranibizumab injection<br>* Other names: Lucentis;|
| Sham Comparator: Control<br>Standard of care therapy | Drug: Intravitreal ranibizumab<br>* Intravitreal ranibizumab injection<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior segment neovascularization |  | 6 months | 
| Best corrected visual acuity |  | 6 months | 
| Number of drugs needed for IOP control |  | 6 months | 
| Need for IOP control surgery |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Neovascular, Ranibizumab, Intraocular pressure, anti-VEGF, intravitreal injection