This trial is active, not recruiting.

Condition myopic choroidal neovascularization
Treatment ranibizumab injection
Phase phase 4
Sponsor Instituto de Olhos de Goiania
Start date July 2009
End date October 2014
Trial size 20 participants
Trial identifier NCT01246089, JN-09-2010-AR


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Myopic eyes with retinal neovascularization
ranibizumab injection
Ranibizumab intravitreal injection of 0,5 mg ( 0.05mL)

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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.

Additional Information

Official title Ranibizumabe Intravitreal Injection for Myopic Choroidal Neovascularization
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Instituto de Olhos de Goiania.