Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

Sponsor

Instituto de Olhos de Goiania (Other)

Overall Status

Completed

CT.gov ID

NCT00797992

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

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

Detailed Description

Nineteen consecutive patients (19 eyes) with subfoveal PM-CNV, 18 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 1.25 mg bevacizumab or 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

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Myopic eyes with retinal neovascularization	Drug: Injection Intravitreal injection of 1.25 mg bevacizumab

Arm

Intervention/Treatment

Experimental: 1

Myopic eyes with retinal neovascularization

Drug: Injection

Intravitreal injection of 1.25 mg bevacizumab

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Myopic 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.