AflibxMyopia: Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization

Sponsor

Instituto de Olhos de Goiania (Other)

Overall Status

Unknown status

CT.gov ID

NCT02033018

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Choroidal Retinal Neovascularization	Drug: Aflibercept Injection	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Nov 1, 2014

Anticipated Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aflibercept injection Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection	Drug: Aflibercept Injection Aflibercept intravitreal injection Other Names: Aflibercept intravitreal injection of 0,5 mg ( 0.05mL

Arm

Intervention/Treatment

Experimental: Aflibercept injection

Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection

Drug: Aflibercept Injection

Aflibercept intravitreal injection

Other Names:

Aflibercept intravitreal injection of 0,5 mg ( 0.05mL

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.