Lucentis for New Onset Neovascular Glaucoma (NVG)

February 13, 2020 updated by: Michael Blair, University of Illinois at Chicago

Randomized Controlled Trial of Lucentis in the Management of New Onset Neovascular Glaucoma

Neovascular glaucoma is a potentially debilitating disease of the eye. Vascular eye disease such as diabetes and vein occlusions can cause the retina to release factors that promote the growth of abnormal blood vessels. These abnormal vessels can grow in the drainage mechanism of the eye causing pressure in the eye to markedly increase. This can potentially cause irreversible damage to the optic nerve from glaucoma leading to permanent blindness and painful eyes. Conventional treatments including laser and freezing therapy take weeks to cause regression in abnormal blood vessel growth. This delay often results in permanent vision loss and pain. New medications targeted at more immediately reducing blood vessel growth may aid in the treatment of this disease.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Hypothesis:

Intravitreal injection of Lucentis prior to conventional treatment for neovascular glaucoma improves overall outcome compared to conventional treatment alone.

Specific Aims:

To determine if pre-treatment with a single intravitreal injection of Lucentis prior to conventional treatment prevents severe vision loss and improves intraocular pressure control compared to conventional treatment alone.

Neovascular glaucoma is a potentially devastating consequence of fibrovascular proliferation of the anterior chamber angle with subsequent obstruction of the trabecular meshwork. The production of peripheral anterior synechiae along the trabecular meshwork leads to progressive angle closure. The subsequent elevation in intraocular pressure is difficult to manage, often leading to rapid progression of glaucoma and significant loss of vision. Enucleation for blind, painful eyes secondary to neovascular glaucoma is not an uncommon sequelae.

Neovascular glaucoma has many etiologic causes, the vast majority resulting from retinal ischemia secondary to relatively common diseases such as central retinal vein occlusion, proliferative diabetic retinopathy and ocular ischemic syndrome (carotid stenosis). (Sivac-Callcott et al., 2001) Vascular endothelial growth factor is likely a major contributor to the development of angle and iris neovascularization. (Ferrara, 2004) Although panretinal photocoagulation and/or cryoablation are mainstays of conventional treatment for neovascular glaucoma, the delayed therapeutic effect of these interventions often results in the formation of peripheral anterior synechiae and permanent angle closure.

Recent limited case series have demonstrated a role for bevacizumab (Avastin) in reducing rubeosis iridis and as an adjunct for neovascular glaucoma. (Grisanti et al., 2006; Davidorf et al., 2006; Iliev et al., 2006; Kahook, Schuman, Noecker, 2006) However, no prospective studies have examined the potential utility of anti-vascular endothelial growth factor agents in the treatment of neovascular glaucoma. Intravitreal Lucentis is the standard of care for the treatment of exudative macular degeneration. Pharmacologic agents such as Lucentis, which selectively inhibit vascular endothelial growth factor may provide an important therapeutic adjunct for the treatment of neovascular glaucoma by more immediately causing regression of angle neovascularization and thereby providing a window for permanent treatment with laser or cryotherapy.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 21 years
  • Diagnosis of neovascular glaucoma (angle neovascularization with or without iris neovascularization and IOP > 21 mm Hg and > 5 mm Hg IOP compared to the fellow eye).
  • Neovascular glaucoma secondary to retinal ischemia (central retinal vein occlusion, proliferative diabetic retinopathy, ocular ischemic syndrome, etc.)

Exclusion Criteria:

  • Pregnancy (positive pregnancy test) or lactation or pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Prior enrollment in the study
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
  • > 270 degrees of closed trabecular meshwork (closure secondary to peripheral anterior synechiae)
  • History of active inflammatory, infectious, or idiopathic keratitis precluding view of the anterior segment structures.
  • Previous intravitreal injections of ranibizumab or bevacizumab in either eye.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Lucentis (ranibizumab) with conventional treatment
Drug: Ranibizumab (Lucentis)
0.5 mg ranibizumab intravitreal injection single dose administration
Other Names:
  • Lucentis
  • ranibizumab
No Intervention: 2
Conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in best corrected visual acuity (BCVA) as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from baseline to Month 6.
Time Frame: Baseline to Month 6.
Baseline to Month 6.

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in angle neovascularization (measured in clock hours by gonioscopy).
Time Frame: Initial visit through Month 6
Initial visit through Month 6
Percent change in permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy).
Time Frame: Initial visit through Month 6
Initial visit through Month 6
Mean change in intraocular pressure measured by applanation tonometry.
Time Frame: Initial visit through Month 6
Initial visit through Month 6
Percent change in iris neovascularization (measured both in clock hours by slit lamp exam and with iris angiography).
Time Frame: Initial visit through Month 6
Initial visit through Month 6
Rates of severe vision loss (visual acuity <20/200, loss of 6 lines or more on ETDRS chart).
Time Frame: Initial Visit through Month 6
Initial Visit through Month 6
Number of intraocular pressure lowering medications needed to control intraocular pressure.
Time Frame: Initial Visit through Month 6
Initial Visit through Month 6
Mean change in optic nerve cupping.
Time Frame: Initial Visit through Month 6
Initial Visit through Month 6
Percent of patients requiring surgical glaucoma procedure to control intraocular pressure (trabeculectomy, seton, or ciliary body destruction).
Time Frame: Study duration
Study duration
Percent of patients requiring pars plana vitrectomy with endolaser.
Time Frame: Study duration
Study duration
Rates of endophthalmitis.
Time Frame: Study duration
Study duration
Rates of rhegmatogenous retinal detachment.
Time Frame: Study duration
Study duration
Final clock hours of permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy)
Time Frame: Month 6 visit
Month 6 visit

Collaborators and Investigators

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

Sponsor

University of Illinois at Chicago

Collaborators

Genentech, Inc.

Investigators

  • Principal Investigator: Michael P Blair, MD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

January 4, 2008

Primary Completion (Actual)

May 15, 2009

Study Completion (Actual)

May 15, 2009

Study Registration Dates

First Submitted

July 29, 2008

First Submitted That Met QC Criteria

July 29, 2008

First Posted (Estimate)

August 1, 2008

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0792
  • FVF4143S (Other Identifier: Genentech, Inc.)

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.

Clinical Trials on Glaucoma

Clinical Trials on Ranibizumab (Lucentis)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe