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Ranibizumab for Myopic Neovascularization

Primary Purpose

Myopic Choroidal Neovascularization

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
ranibizumab injection
Sponsored by
Instituto de Olhos de Goiania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopic Choroidal Neovascularization focused on measuring Ranibizumab, Myopia, Complications, Neovascularization, OCT

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Myopic and CNVM

Exclusion Criteria:

  • Patients with poor compliance

    • Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients).
    • Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
    • Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
    • Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
    • Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
    • Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.

Sites / Locations

  • Instituto de Olhos de Goiania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ranabizumab

Arm Description

Myopic eyes with retinal neovascularization

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 20, 2010
Last Updated
December 31, 2013
Sponsor
Instituto de Olhos de Goiania
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1. Study Identification

Unique Protocol Identification Number
NCT01246089
Brief Title
Ranibizumab for Myopic Neovascularization
Official Title
Ranibizumabe Intravitreal Injection for Myopic Choroidal Neovascularization
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Olhos de Goiania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).
Detailed Description
Twenty consecutive patients (30 eyes) with subfoveal PM-CNV, 9 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Choroidal Neovascularization
Keywords
Ranibizumab, Myopia, Complications, Neovascularization, OCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranabizumab
Arm Type
Experimental
Arm Description
Myopic eyes with retinal neovascularization
Intervention Type
Drug
Intervention Name(s)
ranibizumab injection
Intervention Description
Ranibizumab intravitreal injection of 0,5 mg ( 0.05mL)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Myopic and CNVM Exclusion Criteria: Patients with poor compliance Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients). Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved. Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery. Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods. Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR. Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
Facility Information:
Facility Name
Instituto de Olhos de Goiania
City
Goiania
State/Province
GO
ZIP/Postal Code
74120-050
Country
Brazil

12. IPD Sharing Statement

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Ranibizumab for Myopic Neovascularization

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