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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006785-15-ES
Enrollment
Unknown
Registered
2008-01-11
Start date
2008-03-10
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroidal neovascular membrane in high myopia MedDRA version: 9.1 Level: LLT Classification code 10060823 Term: Choroidal neovascularisation MedDRA version: 9.1 Level: LLT Classification code 10051455 Term: Malignant myopia

Interventions

Trade Name: AVASTIN Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Current Sponsor code: RO487-6646 Other descriptive name: BEVAC

Sponsors

IOBA - Instituto Universitario de Oftalmobiología Aplicada
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Main Objective: Visual acuity improvement Reduction of membrane thickness in OCT and FAG;Secondary Objective: Security of treatment: assessment of intravitreal injection of bevacizumab complications.;Primary end point(s): Best corrected visual acuity improvement based in ETDRS testing Central retinal thickness assessed by OCT Neovascularization activity determined by OCT and FAG—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026