Glaucoma, Neovascular Clinical Trial
Official title:
Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study
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.
Status | Not yet recruiting |
Enrollment | 28 |
Est. completion date | October 2018 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
LEANDRO CABRAL ZACHARIAS | Novartis |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraocular pressure | 6 months | Yes | |
Secondary | Anterior segment neovascularization | 6 months | No | |
Secondary | Best corrected visual acuity | 6 months | No | |
Secondary | Number of drugs needed for IOP control | 6 months | No | |
Secondary | Need for IOP control surgery | 6 months | No |
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