TANDEM - A randomised controlled trial of standard and low dose Avastin for wet macular degeneration.

Phase 1

• Conditions: eovascular (wet) age-related macular degeneration; Therapeutic area: Diseases [C] - Eye Diseases [C11]; MedDRA version: 14.1 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina System Organ Class: 100000004853

• Registration Number: EUCTR2009-014280-38-GB
• Lead Sponsor: ottingham University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-03
• Study Completion: 2017-03-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 812

Inclusion Criteria

•Any patient newly referred for the treatment of nAMD or reactivation of nAMD, i.e. disease stable with no treatment for nAMD to either eye for the previous 6 months, who is considered eligible for anti-VEGF treatment in the NHS.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1400

Exclusion Criteria

• 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 • Patients with known hypersensitivity to recombinant human or humanised antibodies

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the relative effectiveness of standard versus low dose Avastin® (bevacizumab) for intravitreal injection on visual outcome in patients with nAMD.;Secondary Objective: 1. To estimate the effectiveness of more frequent vs. less frequent VEGF inhibition in improving or maintaining visual function, with stringent criteria for restarting treatment to prevent visual acuity loss in patients receiving less frequent treatment. 2. To describe the adverse effects of different Avastin® doses and review regimens.;Primary end point(s): The primary endpoint is defined by the time-to-an-event, i.e. vision deterioration as measured with distance visual acuity assessments using the logMAR scale. This allows any period of observation in the trial, however short, to contribute to answering the trial objectives. With such an outcome, there is no need to define a primary endpoint in time.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Secondary endpoints will be analysed 18 months after the start of recruitment, 30 months after the start of recruitment and then annually, unless otherwise stated, using data available at the time.;Secondary end point(s): (i)Frequencies of adverse effects of treatment (ii)Corrected distance visual acuity (VAlogMAR), measured as the number of letters read on a standard ETDRS chart (testing initially at 3 or 4 metres depending on the facilities at sites and then at 1 metre if <20 letters are read at 3 or 4 metres; total letters read are scored ‘as if’ viewing at 1 metre).