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

Glaucoma, Neovascular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02914626
• Other study ID #: USaoPauloGH 294.326
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 22, 2016
• Last updated: September 24, 2016
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: September 2016
• Source: University of Sao Paulo General Hospital
• Contact: Leandro C Zacharias, MD, PhD
• Phone: 5511-2661-7871
• Email: lczacharias[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular
• Ranibizumab

Intervention

Drug:
• Intravitreal ranibizumab
Intravitreal ranibizumab injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
LEANDRO CABRAL ZACHARIAS	Novartis

Outcome

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