Condition category
Eye Diseases
Date applied
29/06/2009
Date assigned
22/09/2009
Last edited
23/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Alexander Foss

ORCID ID

Contact details

Department of Ophthalmology
Nottingham University Hospitals NHS Trust
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09OY006

Study information

Scientific title

A randomised controlled Trial of high and low dose Avastin® for Neovascular macular Degeneration in the East Midlands

Acronym

TANDEM

Study hypothesis

It is hypothesised that Avastin® remains effective in treating neovascular age-related macular degeneration (nAMD) when administered in smaller doses and/or at less-frequent intervals than those typically used in clinical settings.

Please note that as of 10/04/2013, the anticipated end date for this trial was updated from 01/01/2013 to 01/01/2016

Ethics approval

Not provided at time of registration

Study design

Multi-centre four group (factorial design) randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neovascular (wet) age-related macular degeneration (nAMD)

Intervention

All patients will receive intraocular injections of Avastin® to treat nAMD. Patients will receive either a conventional dose (1.250 mg) or a low dose (0.625 mg) each month for three consecutive months. Following this, patients will receive further injections (continuing the same dose size) as required at review clinics. Patients will return for reviews either monthly or two-monthly.

As such there will be four different intervention groups:
L1: low dose Avastin®, one-monthly review
L2: low dose Avastin®, two-monthly review
H1: high (conventional) dose Avastin®, one-monthly review
H2: high (conventional) dose Avastin®, two-monthly review

Treatment will continue until the affected eye(s) demonstrate reduced/reversed symptoms or until patients are withdrawn.

Intervention type

Drug

Phase

Phase IV

Drug names

Avastin®

Primary outcome measures

Time to an event, i.e. vision deterioration.

Secondary outcome measures

1. Frequencies of adverse effects of treatment
2. Corrected distance visual acuity (VAlogMAR), measured as the number of letters read on a standard ETDRS chart at 1 metre.

Measured 18 and 30 months after the start of recruitment and then annually.

Overall trial start date

01/01/2010

Overall trial end date

01/01/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults of either sex aged 50 years and older
2. Newly referred for the treatment of nAMD
3. Corrected distance logarithm of the minimum angle of resolution visual acuity (VAlogMAR) greater than or equal to 20 letters and less than 70 letters read on a standard ETDRS chart at 1 metre
4. Any component of the neovascular lesion (choroidal neovascularisation [CNV], blood, serous pigment epithelial detachment, elevated blocked fluorescence) involving the centre of the fovea

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

1. Aged less than 50 years
2. Corrected VAlogMAR less than 20 letters at 1 metre
3. Long standing CNV evidenced by the presence of fibrosis in excess of 50% of the total lesion
4. Greatest linear diameter greater than 6000 µm (equivalent to about 12 disc diameters)
5. Argon laser treatment to the proposed study eye within the last 6 months
6. Presence of thick blood involving the centre of the fovea
7. Presence of other active ocular disease causing concurrent vision loss, e.g. diabetic retinopathy
8. Previous treatment with photodynamic therapy (PDT) or a vascular endothelial growth factor (VEGF) inhibitor in either eye
9. Patients with 8 or more diopters of myopia
10. Pregnant and or lactating women
11. Women with child bearing potential (i.e. not sterilised or not post-menopausal) who are unwilling to use contraception
12. Men with a spouse or partner with child bearing potential unless the participant has agreed to use condoms
13. Patients with known hypersensitivity to recombinant human or humanised antibodies

Recruitment start date

01/01/2010

Recruitment end date

01/01/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust (UK)

Sponsor details

Research and Development Department
E11 Curie Court
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor type

Government

Website

http://www.nuh.nhs.uk/

Funders

Funder type

Government

Funder name

East Midlands Primary Care Trust Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25873213

Publication citations

Additional files

Editorial Notes