A randomised control trial of alternative treatments to Inhibit VEGf in Age-related choroidal Neovascularisation(IVAN) - IVA

Phase 1

• Conditions: Choroidal neovascularisation in age related macular degeneration; MedDRA version: 14.0 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina System Organ Class: 10015919 - Eye disorders

• Registration Number: EUCTR2007-001281-33-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

•Adults of either sex aged 50 years and older;
•Newly referred for the treatment of nAMD in the first or second eye;
•Corrected distance logMAR visual acuity (VAlogMAR) =25 letters read on a standard ETDRS chart at 1 metre;
•Any component of the neovascular lesion (CNV, blood, serous pigment epithelial detachment, elevated blocked flourescence) involving the centre of the fovea.
If a fellow eye develops CNV from AMD, it will be treated with the optimum locally available treatment.

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

•Age less than 50 years
•Corrected VAlogMAR <25 letters at 1 metre;
•Long standing CNV evidenced by the presence of fibrosis in excess of 50% of the total lesion;
•Greatest linear diameter >6000µm (equivalent to about 12 disc diameters)
•Argon laser treatment to the proposed study eye within the last 6 months
•Presence of thick blood involving the centre of the fovea
•Presence of other active ocular disease causing concurrent vision loss, e.g. diabetic retinopathy.
•Patients with 8 or more dioptres of myopia.
•Previous treatment with PDT or a VEGF inhibitor in the eye being considered for inclusion.
•Pregnant and or lactating women
•Women with child bearing potential (i.e. not sterilised or not post menopausal) who are unwilling to use contraception
•Men with a spouse or partner with child bearing potential unless the participant has agreed to use condoms
A past medical history of cardiovascular disease or cardiovascular comorbidity, e.g. previous myocardial infarction or stroke, current angina, will not be an exclusion criterion. However, such factors will be documented carefully at the time of recruitment, and the potential benefits and harms of treatment discussed carefully with potential participants.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified