Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization

Phase 4

• Conditions: Choroidal Retinal Neovascularization
• Interventions: Drug: Aflibercept Injection

• Registration Number: NCT02033018
• Lead Sponsor: Instituto de Olhos de Goiania

Brief Summary

The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary

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

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-31
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-09
• Last Update Submitted: 2014-01-09
• Study First Posted: 2014-01-10
• Last Update Posted: 2014-01-10
• Primary Completion: 2014-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept injection	Aflibercept Injection	Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection

Primary Outcome Measures

Name	Time	Method
Efficacy	To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.	8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. 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. AII 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 1 year.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.	8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. 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.

Trial Locations

Locations (1)

Instituto de Olhos de Goiania; 🇧🇷 Goiania, GO, Brazil