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

September 24, 2016 updated by: LEANDRO CABRAL ZACHARIAS
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ranibizumab
Standard of care therapy plus intravitreal ranibizumab injections
Drug: Intravitreal ranibizumab
Intravitreal ranibizumab injection
Other Names:
  • Lucentis
Sham Comparator: Control
Standard of care therapy
Drug: Intravitreal ranibizumab
Intravitreal ranibizumab injection
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Anterior segment neovascularization
Time Frame: 6 months
6 months
Best corrected visual acuity
Time Frame: 6 months
6 months
Number of drugs needed for IOP control
Time Frame: 6 months
6 months
Need for IOP control surgery
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEANDRO CABRAL ZACHARIAS

Collaborators

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 24, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USaoPauloGH 294.326

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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