Silmän sisäisten lääkeainepistosten aikaan saama hermoston uudelleen muokaantuvuus

Conditions: Wet age-related macular degeneration, diabetic macular edema, central retinal vein occlusion
MedDRA version: 18.1Level: LLTClassification code 10012675Term: Diabetic macular retinopathySystem Organ Class: 100000004853
MedDRA version: 18.1Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 100000004853
MedDRA version: 18.1Level: LLTClassification code 10015902Term: Exudative senile macular degeneration of retinaSystem Organ Class: 100000004853
Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

Registration Number: EUCTR2012-000765-20-FI

Lead Sponsor: Kuopion yliopistollinen sairaala/silmätautien poliklinikka

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

- 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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