A Phase IV Open-Labelled Prospective Pilot Study of Intravitreal Macugen (pegaptanib) for Ischaemic Diabetic Macular Oedema (MIDME study) - Intravitreal Macugen for Ischaemic Diabetic Macular Oedema

• Conditions: Ischaemic diabetic macular oedema.; MedDRA version: 12Level: SOCClassification code 10057915Term: diabetic macular oedema

• Registration Number: EUCTR2009-017540-13-GB
• Lead Sponsor: Clinical Trials and Research Governance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Participant is willing and able to give informed consent for participation in the study.
•Male or Female, aged 18 years or above.
•DME
•BCVA 20/32 to 20/320 inclusive
•Central OCT thickness > 300 microns
•Enlargement of FAZ (ischaemia or capillary drop out of >30% on FFA)
•Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
•Able (in the Investigator's opinion) and willing to comply with all study requirements e.g. attending for tests and treatment every 6 weeks.
•Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
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

•Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
•Any significant disease or disorder, e.g. recent stroke or myocardial infarction, which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
•Participants who have participated in another research study involving an investigational product in the past 12 weeks
•Laser within 3 months
•Intraocular surgery within 6 months
•Known allergy to Macugen (pegaptanib)
•Known allergy to fluorescein

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: How do 6-weekly injections of Macugen (pegaptanib) into the vitreous gel at the back of the eye (intravitreal injections) affect the size of the FAZ in ischaemic DME after 30 weeks?<br>;Secondary Objective: What is the effect of 6-weekly intravitreal Macugen (pegaptanib) injections on best corrected visual acuity and central foveal thickness in ischaemic DME at 30 weeks? <br>;Primary end point(s): Changes in the size of foveal avascular zone (FAZ) at 30 weeks.