Ranibizumab for Myopic Neovascularization

NCT ID: NCT01246089

Last Updated: 2014-01-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-11-30

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.

Conditions

Myopic Choroidal Neovascularization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ranabizumab

Myopic eyes with retinal neovascularization

Group Type: EXPERIMENTAL

ranibizumab injection

Intervention Type: DRUG

Ranibizumab intravitreal injection of 0,5 mg ( 0.05mL)

Interventions

ranibizumab injection

Ranibizumab intravitreal injection of 0,5 mg ( 0.05mL)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Olhos de Goiania

OTHER

Sponsor Role: lead

Responsible Party

Joao Nassaralla

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto de Olhos de Goiania

Goiânia, Goiás, Brazil

Countries

Brazil

Other Identifiers

JN-09-2010-AR

Identifier Type: -

Identifier Source: org_study_id