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The Effect of Intravitreal Bevacizumab Injections in Patients with Macular Oedema Caused by AMD, CRVO or DME on the Plasticity of Nerves Studied by Visual Evoked Potentials

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000765-20-FI

Enrollment

Registered

2015-11-20

Start date

2015-11-27

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Wet age-related macular degeneration, diabetic macular edema, central retinal vein occlusion MedDRA version: 18.1 Level: LLT Classification code 10012675 Term: Diabetic macular retinopathy System Organ Class: 100000004853 MedDRA version: 18.1 Level: LLT Classification code 10007972 Term: Central retinal vein occlusion System Organ Class: 100000004853 MedDRA version: 18.1 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina System Organ Class: 100000004

Interventions

Trade Name: Avastin Product Name: Bevacizumab Product Code: RO4876646/F02 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All subjects are over 18 years old and subjects in AMD group are over 65 years old. The symptoms of decreased central vision or blurred vision is not allowed to have lasted longer than eigth weeks before entering the study. In CRVO group only non-ischemic subtype is taken into this study. A control group consists healthy subjects over 18 years old without macular oedema. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Pregnancy - The eye previously treated with anti-VEGF injections - Opthalmic surgery previously, only cataract surgery wihtout complications is allowed - In AMD and CRVO groups diabetes is exclusion criteria. Anti-VEGF injections or ophtalmic surgery of fellow eye is not an exclusion criteria.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate how the visual evoked potential (VEP) changes after the anti-VEGF injections ;Secondary Objective: Not applicable;Primary end point(s): The VEP changes after the anti-VEGF injections;Timepoint(s) of evaluation of this end point: 12-16 weeks after the beginning of the study	—

Secondary

Measure	Time frame
Secondary end point(s): The correlation of VEP changes to the clinical findings;Timepoint(s) of evaluation of this end point: 12-16 weeks after the beginning of the study	—

Countries

Finland

Contacts

Public ContactSilmätautien poliklinikka

Kuopion yliopistollinen sairaala

pasi.vottonen@kuh.fi

Outcome results

None listed

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