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Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

Primary Purpose

Age Related Macular Degeneration

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

bevacizumab

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring bevacizumab, AMD, Complications, Visual acuity, OCt, Age Macular Degeneration

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.
Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
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.

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).
Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP

Secondary Outcome Measures

Ocular side effects (infection, RD, IOP rise, cataract)

Full Information

NCT ID

NCT00556348

First Posted

November 9, 2007

Last Updated

November 19, 2011

Sponsor

Instituto de Olhos de Goiania

1. Study Identification

Unique Protocol Identification Number

NCT00556348

Brief Title

Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

Official Title

Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

November 2008 (Actual)

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

To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab (Avastin, Roche, Rio de Janeiro, Brazil) in patients with choroidal neovascularization secondary to age-related macular degeneration.

Detailed Description

We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age Related Macular Degeneration

Keywords

bevacizumab, AMD, Complications, Visual acuity, OCt, Age Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

bevacizumab

Intervention Description

1.25mg

Primary Outcome Measure Information:

Title

Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP

Secondary Outcome Measure Information:

Title

Ocular side effects (infection, RD, IOP rise, cataract)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Myopic CNVM, Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM. 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. 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). Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joao J Nassaralla, Jr

Organizational Affiliation

UnB and IOG

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

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