Ranibizumab for Myopic Neovascularization

Myopic Choroidal Neovascularization Clinical Trial

Official title:

Ranibizumabe Intravitreal Injection for Myopic Choroidal Neovascularization

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01246089
• Other study ID #: JN-09-2010-AR
• Status: Active, not recruiting
• Phase: Phase 4
• First received: November 20, 2010
• Last updated: December 31, 2013
• Start date: July 2009
• Est. completion date: November 2014

Study information

• Verified date: December 2013
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopia
• Myopic Choroidal Neovascularization
• Neovascularization, Pathologic

Intervention

Drug:
• ranibizumab injection
Ranibizumab intravitreal injection of 0,5 mg ( 0.05mL)

Locations

Country	Name	City	State
Brazil	Instituto de Olhos de Goiania	Goiania	GO

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania

Country where clinical trial is conducted

Brazil,