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Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization (AflibxMyopia)

Primary Purpose

Choroidal Retinal Neovascularization

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Aflibercept 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 Choroidal Retinal Neovascularization focused on measuring Aflibercept, 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
  • Instituto de Olhos de GoianiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aflibercept injection

Arm Description

Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection

Outcomes

Primary Outcome Measures

Efficacy
8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. 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. AII 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 1 year.

Secondary Outcome Measures

Safety and Tolerability
8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. 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.

Full Information

First Posted
December 31, 2013
Last Updated
January 9, 2014
Sponsor
Instituto de Olhos de Goiania
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1. Study Identification

Unique Protocol Identification Number
NCT02033018
Brief Title
Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization
Acronym
AflibxMyopia
Official Title
Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
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
Choroidal Retinal Neovascularization
Keywords
Aflibercept, 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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept injection
Arm Type
Experimental
Arm Description
Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Aflibercept Injection
Other Intervention Name(s)
Aflibercept intravitreal injection of 0,5 mg ( 0.05mL
Intervention Description
Aflibercept intravitreal injection
Primary Outcome Measure Information:
Title
Efficacy
Description
8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. 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. AII 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 1 year.
Time Frame
To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.
Secondary Outcome Measure Information:
Title
Safety and Tolerability
Description
8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. 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.
Time Frame
To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.

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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raquel Monteiro
Phone
55 62 3220 2500
First Name & Middle Initial & Last Name or Official Title & Degree
João J Nassaralla, Jr
Phone
55 62 3220 2545
Email
nassaral@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joao J Nassaralla, Jr
Organizational Affiliation
Instituto de Olhos de Goiânia
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Olhos de Goiania
City
Goiania
State/Province
GO
ZIP/Postal Code
74120-050
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Instituto de Olhos de Goiania
City
Goiania
State/Province
GO
ZIP/Postal Code
74120-050
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Monteiro
Phone
55 62 3220 2511
First Name & Middle Initial & Last Name & Degree
João J Nassaralla, JR
Phone
55 62 3220 2545
Email
nassaral@terra.com.br
First Name & Middle Initial & Last Name & Degree
Joao J Nassaralla, Jr

12. IPD Sharing Statement

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Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization

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