Macular structure and function after intravitreal injection of bevacizumab for wet macular degeneration a interventional study. - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-006014-18-IT

Enrollment

Registered

2006-06-23

Start date

2005-12-15

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

Macular degeneration MedDRA version: 6.1 Level: PT Classification code 10025409

Interventions

Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.25-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Exudative age related macular degeneration age 60 and visual acuity between FC finger count and 0,5 decimal ETDRS table . The location of choroidal neovascularization CNV should be subfoveal either classic 4 disc diameter, minimally classic CNV or occult CNV, as well as RAP lesions more than II stage, lesions with large haemorrhagic component, large pigment epithelial detachments PED . Are also included in the study patients that are not eligible for photodinamic therapy PDT because they do not accomplish the PDT treatment criteria low vision, presence of disciform scar , or because they refuse PDT or other treatment for the cure of their pathology. 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: Patients with exudative age related macular degeneration with classic CNV 4 disc diameter. Patients with exudative maculopathy CNV not related to age related macular degeneration such as pathologic myopia, inflammation, angioid streaks. Patients with media opacity in which is not possible to evaluate the details the fundus of the eye

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess macular structure and function by visual acuity ETDRS , optical coherence tomography OCT3 , focal electroretinogram FERG , microperimetry, fluorescein and indocyanine angiography before and after intravitreal bevacizumab administration for wet age related macular degeneration.;Secondary Objective: To assess macular structure and function by visual acuity ETDRS , optical coherence tomography OCT3 , focal electroretinogram FERG , microperimetry, fluorescein and indocyanine angiography before and after intravitreal bevacizumab administration for wet age related macular degeneration.;Primary end point(s): To reduct the maculare degeneration and to improve the visual acuity ETDRS	—

Measure

Time frame

Main Objective: To assess macular structure and function by visual acuity ETDRS , optical coherence tomography OCT3 , focal electroretinogram FERG , microperimetry, fluorescein and indocyanine angiography before and after intravitreal bevacizumab administration for wet age related macular degeneration.;Secondary Objective: To assess macular structure and function by visual acuity ETDRS , optical coherence tomography OCT3 , focal electroretinogram FERG , microperimetry, fluorescein and indocyanine angiography before and after intravitreal bevacizumab administration for wet age related macular degeneration.;Primary end point(s): To reduct the maculare degeneration and to improve the visual acuity ETDRS

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Countries

Italy

Outcome results

None listed

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