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Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

Primary Purpose

Myopic Choroidal Neovascularization

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Injection

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Myopic 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

Arm Description

Myopic eyes with retinal neovascularization

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00797992

First Posted

November 24, 2008

Last Updated

November 24, 2008

Sponsor

Instituto de Olhos de Goiania

1. Study Identification

Unique Protocol Identification Number

NCT00797992

Brief Title

Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

Official Title

Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Instituto de Olhos de Goiania

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

Detailed Description

Nineteen consecutive patients (19 eyes) with subfoveal PM-CNV, 18 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 1.25 mg bevacizumab or 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

Bevacizumab, 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

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Myopic eyes with retinal neovascularization

Intervention Type

Drug

Intervention Name(s)

Injection

Intervention Description

Intravitreal injection of 1.25 mg bevacizumab

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Myopic 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joao J Nassaralla, PhD

Organizational Affiliation

Instituto de Olhos de Goiania

Official's Role

Study Chair

Facility Information:

Facility Name

Instituto de Olhos de Goiania

City

Goiania

State/Province

ZIP/Postal Code

74120-050

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

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