Status:
COMPLETED
Intravitreal Macugen for Ischaemic Diabetic Macular Oedema
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Pfizer
Conditions:
Diabetic Macular Oedema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Diabetic macular oedema (DME) is one of the leading causes of blindness in the United Kingdom's working population. It affects the macula, which lies at the centre of the retina, at the back of the ey...
Detailed Description
Diabetic macular oedema: A combination of increasing longevity and increasing obesity is causing a rise in the incidence of diabetes and its associated complications such as diabetic retinopathy. Alm...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Any co-existing ocular disease (with the exception of cataract)
- 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
- Significant renal impairment, i.e. creatinine clearance \< 20mL/min
- 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 pegaptanib (Macugen \[TM\])
- Known allergy to fluorescein
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01175070
Start Date
January 1 2011
End Date
March 1 2013
Last Update
December 24 2014
Active Locations (1)
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1
Oxford Eye Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU