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

NCT ID: NCT02914626

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-10-31

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.

Conditions

Glaucoma, Neovascular; Ranibizumab

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ranibizumab

Standard of care therapy plus intravitreal ranibizumab injections

Group Type: EXPERIMENTAL

Intravitreal ranibizumab

Intervention Type: DRUG

Intravitreal ranibizumab injection

Control

Standard of care therapy

Group Type: SHAM_COMPARATOR

Intravitreal ranibizumab

Intervention Type: DRUG

Intravitreal ranibizumab injection

Interventions

Intravitreal ranibizumab

Intravitreal ranibizumab injection

Intervention Type: DRUG

Other Intervention Names

Lucentis

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

LEANDRO CABRAL ZACHARIAS

OTHER

Sponsor Role: lead

Responsible Party

LEANDRO CABRAL ZACHARIAS

Attending - Department of Ophthalmology- University of Sao Paulo

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Leandro C Zacharias, MD, PhD

Role: CONTACT

lczacharias@gmail.com

5511-2661-7871

References

Rittiphairoj T, Roberti G, Michelessi M. Anti-vascular endothelial growth factor for neovascular glaucoma. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD007920. doi: 10.1002/14651858.CD007920.pub4.

Reference Type: DERIVED

PMID: 37010901 (View on PubMed)

Other Identifiers

USaoPauloGH 294.326

Identifier Type: -

Identifier Source: org_study_id