Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study
1 other identifier
interventional
28
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2016
CompletedFirst Posted
Study publicly available on registry
September 26, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedSeptember 27, 2016
September 1, 2016
1 year
September 22, 2016
September 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular pressure
6 months
Secondary Outcomes (4)
Anterior segment neovascularization
6 months
Best corrected visual acuity
6 months
Number of drugs needed for IOP control
6 months
Need for IOP control surgery
6 months
Study Arms (2)
Ranibizumab
EXPERIMENTALStandard of care therapy plus intravitreal ranibizumab injections
Control
SHAM COMPARATORStandard of care therapy
Interventions
Intravitreal ranibizumab injection
Eligibility Criteria
You may qualify if:
- IOP greater than 24 mmHg
- Iris or anterior chamber neovascularization
- At least 120 degrees of opened anterior chamber angle
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEANDRO CABRAL ZACHARIASlead
- Novartiscollaborator
Related Publications (1)
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.
PMID: 37010901DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending - Department of Ophthalmology- University of Sao Paulo
Study Record Dates
First Submitted
September 22, 2016
First Posted
September 26, 2016
Study Start
October 1, 2016
Primary Completion
October 1, 2017
Study Completion
October 1, 2018
Last Updated
September 27, 2016
Record last verified: 2016-09