Macular structure and function after intravitreal injection of bevacizumab for vascular retinopathy a interventional study. - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001678-25-IT

Enrollment

Registered

2006-06-23

Start date

2006-02-16

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

vascular retinopathy MedDRA version: 6.1 Level: PT Classification code 10038923

Interventions

Pharmaceutical Form: 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: 20 patients age 18 , with visual acuity between FC finger count and 0,5 decimal ETDRS table , with vascular retinopathy macular edema secondary to diabetes, central vein occlusion, branch vein occlusion and Irvine Gass syndrome, proliferative diabetic retinopathy and neovascular glaucoma. 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 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 vascular retinopathy.;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 vascular retinopathy.;Primary end point(s): Safety considerations, along with assessments of changes from baseline in visual acuity score, FERG amplitude and phase, microperimetry foveal sensibility, OCT measurements and angiographic characteristics.	—

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 vascular retinopathy.;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 vascular retinopathy.;Primary end point(s): Safety considerations, along with assessments of changes from baseline in visual acuity score, FERG amplitude and phase, microperimetry foveal sensibility, OCT measurements and angiographic characteristics.

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Countries

Italy

Outcome results

None listed

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