EFFICACY AND SECURITY OF INTRAVITREAL BEVACIZUMAB IN THE TREATMENT OF CHOROIDAL NEOVASCULAR MEMBRANES ASSOCIATED TO HIGH MYOPIA EVALUACIÓN DE LA EFICACIA Y SEGURIDAD DE LA INYECCIÓN INTRAVÍTREA DE BEVACIZUMAB EN LA NEOVASCULARIZACIÓN COROIDEA ASOCIADA A LA MIOPÍA MAGNA

• Conditions: Choroidal neovascular membrane in high myopia; MedDRA version: 9.1Level: LLTClassification code 10060823Term: Choroidal neovascularisation; MedDRA version: 9.1Level: LLTClassification code 10051455Term: Malignant myopia

• Registration Number: EUCTR2007-006785-15-ES
• Lead Sponsor: IOBA - Instituto Universitario de Oftalmobiología Aplicada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Signed informed consent
2. Signed data protection consent
3. Negative pregnancy test in fertile women at baseline.
4. Age 18+
5. High myopia
6. Active choroidal neovascularization (subfoveolar/yuxtafoveolar)
7. Visual acuity loss of less than 6 months of evolution
8. No atrophic or fibrotic component that may prevent visual acuity improvement.
9. Fertile women must commit to use a reliable contraceptive method during the trial.
10. Photodinamic Therapy allowed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Previous vitrectomy in Study Eye
2. Tractional maculopathy and/or epiretinal membrane assessed by OCT
3. Any media opacities that may prevent the adequate assessment of eye fundus.
4. Pseudoaphakia or non integrity of lens´ posterior capsule
5. Patient with great possibilities of not being able to complete the study, based in PIs judgement.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified