Intravitreal Ranibizumab (Lucentis®) for Neovascular Glau... | NCT02914626

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

NCT02914626

Sponsor

LEANDRO CABRAL ZACHARIAS

Status

Unknown status

Last Update Posted

Sep 27, 2016Estimated

Enrollment

28Estimated

Phase

Phase 3

Conditions

Glaucoma, Neovascular
Ranibizumab

Interventions

Intravitreal ranibizumab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2018Estimated

First Submitted Date

Sep 22, 2016

First Submission Date that Met QC Criteria

Sep 23, 2016

First Posted Date

Sep 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

LEANDRO CABRAL ZACHARIAS, Attending - Department of Ophthalmology- University of Sao Paulo, University of Sao Paulo General HospitalSponsor-Investigator

Lead Sponsor

LEANDRO CABRAL ZACHARIASOTHER

Collaborators

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ranibizumab	Experimental	Standard of care therapy plus intravitreal ranibizumab injections	Drug: Intravitreal ranibizumab
Control	Sham Comparator	Standard of care therapy	Drug: Intravitreal ranibizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal ranibizumab	Drug	Intravitreal ranibizumab injection	Control Ranibizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraocular pressure		6 months

Secondary Outcomes

Measure	Description	Time Frame
Anterior segment neovascularization		6 months
Best corrected visual acuity		6 months
Number of drugs needed for IOP control

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leandro C Zacharias, MD, PhD	Contact	5511-2661-7871		lczacharias@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37010901	Derived	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.

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins