Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

November 24, 2008 updated by: Instituto de Olhos de Goiania
To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • GO
      • Goiania, GO, Brazil, 74120-050
        • Instituto de Olhos de Goiania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Myopic eyes with retinal neovascularization
Drug: Injection
Intravitreal injection of 1.25 mg bevacizumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Olhos de Goiania

Investigators

  • Study Chair: Joao J Nassaralla, PhD, Instituto de Olhos de Goiania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

November 1, 2008

Study Completion (ACTUAL)

November 1, 2008

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (ESTIMATE)

November 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2008

Last Update Submitted That Met QC Criteria

November 24, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JN-05-2008-AR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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