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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02914626
Enrollment
28
Registered
2016-09-26
Start date
2016-10-31
Completion date
2018-10-31
Last updated
2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Neovascular, Ranibizumab

Keywords

Glaucoma, Neovascular, Ranibizumab, Intraocular pressure, anti-VEGF, intravitreal injection

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.

Interventions

Intravitreal ranibizumab injection

Sponsors

Novartis
CollaboratorINDUSTRY
LEANDRO CABRAL ZACHARIAS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Intraocular pressure6 months

Secondary

MeasureTime frame
Anterior segment neovascularization6 months
Best corrected visual acuity6 months
Number of drugs needed for IOP control6 months
Need for IOP control surgery6 months

Contacts

Primary ContactLeandro C Zacharias, MD, PhD
lczacharias@gmail.com5511-2661-7871

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026