Clinical trial NCT02914626: Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study
Official title: Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glaucoma, Neovascular
Ranibizumab
Keywords: Glaucoma, Neovascular
Ranibizumab
Intraocular pressure
anti-VEGF
intravitreal injection
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2016-09-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular pressure
timeFrame: 6 months
Secondary outcomes:
measure: Anterior segment neovascularization
timeFrame: 6 months
measure: Best corrected visual acuity
timeFrame: 6 months
measure: Number of drugs needed for IOP control
timeFrame: 6 months
measure: Need for IOP control surgery
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: