Ischaemic diabetic macular oedema. MedDRA version: 12 Level: SOC Classification code 10057915 Term: diabetic macular oedema
Conditions
Interventions
Trade Name: Macugen 0.3mg
Product Name: Pegaptanib sodium 0.3mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pegaptanib sodium
CAS Number: 222716-86-1
Other descriptive name: Macug
Sponsors
Clinical Trials and Research Governance
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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? ;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? ;Primary end point(s): Changes in the size of foveal avascular zone (FAZ) at 30 weeks. | — |
Countries
United Kingdom
Outcome results
None listed