Condition category
Eye Diseases
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
14/07/2016
Prospective/Retrospective
Retrospectively 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

Ms Narinder Sangha

ORCID ID

Contact details

Frimley Park Hospital
Maple House
Surrey
GU16 7UJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6648

Study information

Scientific title

A prospective randomised controlled trial assessing the efficacy of Pegatanib sodium (Macugen®) in the prevention of proliferative diabetic retinopathy

Acronym

Macugen®

Study hypothesis

Multi-centre prospective randomised controlled study to assess the efficacy of intravitreal Macugen® injections to prevent the development of proliferative diabetic retinopathy (early treatment diabetic retinopathy study [ETDRS] = 61) compared to standard care (no treatment) in patients with severe non-proliferative diabetic retinopathy (sNPDR) (ETDRS = 53 A - E).

The objective of the study is to assess whether Macugen® given at these time points of diabetic retinopathy can prevent the conversion to sight threatening PDR.

Ethics approval

MREC approved (ref: 08/H1102/91)

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology

Intervention

90 subjects with ETDRS 53 A - E will be enrolled into the study. Baseline examination will include of best-corrected visual acuity (BCVA), fundus examination, 7-field retina colours and fundus fluorescein angiography with peripheral sweeps. The patients in the treatment arm will have 3 injections of intravitreal Macugen® 0.3 mg at baseline, 6 weeks and 12 weeks. All patients will be followed up at 12 weekly intervals.

Treatment group: baseline, week 6, 12, 24, 36, 48, 60, 72, 84, 96 and 108 weeks
Control arm: baseline, 12, 24, 36, 48, 60, 72, 84, 96 and 108 weeks

Follow up investigation include BCVA, fundus examination and 7-field retinal colour photographs at every visit. FFA with peripheral sweeps will be done at 12, 36, 60, 84 and 108 weeks follow-up. Pan retinal photocoagulation (PRP) will be carried out at any visit if the level of retinopathy progresses to ETDRS = 61. Subjects will be evaluated for ocular and systemic adverse events at all visits and any unscheduled visits.

Intervention type

Drug

Phase

Phase IV

Drug names

Pegatanib sodium (Macugen®)

Primary outcome measures

The proportion of eyes that progress to ETDRS = 61 following three injections of intravitreal Macugen®

Secondary outcome measures

1. The mean change in size of foveal avascular zone (FAZ) from baseline to end of 12 months and 24 months
2. The rate (timepoint) of development of neovascularisation
3. Rates of ocular and non-ocular adverse events
4. The visual outcome in the study eye will be compared to control eyes

Overall trial start date

01/01/2009

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned Sample Size: 90

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2009

Recruitment end date

01/01/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Frimley Park Hospital
Surrey
GU16 7UJ
United Kingdom

Sponsor information

Organisation

Frimley Park Hospital NHS Foundation Trust (UK)

Sponsor details

Maple House
Portsmouth Road
Frimley
Surrey
GU16 7UJ
United Kingdom

Sponsor type

Government

Website

http://www.frimleypark.nhs.uk/

Funders

Funder type

Industry

Funder name

Pfizer (UK)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

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

Publication citations

Additional files

Editorial Notes

14/07/2016: No publications found, study status unverified