An exploratory phase III prospective open-label clinical study on monthly OCT monitoring of the effects of Ozurdex for macular oedema related to retinal vascular diseases - OCTOME Study

• Conditions: Macular oedema related to retinal vascular diseases; Level: LLTClassification code 10025415Term: Macular oedema

• Registration Number: EUCTR2010-023110-30-GB
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-30
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Aged 18 or above
2.Ability to provide informed consent
3.Diagnosis of macular oedema secondary to diabetic maculopathy, branch and central retinal vein occlusion or pseudophakic cystoid macular oedema or post inflammatory macular oedema
4.Central macular thickness on OCT should be above 250µm
5.Best corrected visual acuity in the study eye between 37 and 68 letters

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

1.Any other eye disease which could mask macular oedema
2.Known uncontrolled systemic disease or current immunosuppressive disease.
3.Initiation of medical therapy for diabetes or a change from oral hypoglycaemic agents to insulin therapy within 4 months prior to the screening visit
4.Renal failure requiring haemodialysis or peritoneal dialysis within 6 months prior to screening visit
5.Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (e.g., severe macular ischemia, extensive macular laser scarring or atrophy)
6.Presence of an epiretinal membrane or vitreo-retinal interface changes in the study eye which, in the opinion of the investigator, is the primary cause of macular oedema, or is severe enough to prevent improvement in visual acuity despite reduction in macular oedema
7.Active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
8.Advanced glaucoma which cannot be adequately controlled by medicinal products alone.
9.History of IOP elevation in response to steroid treatment in either eye that resulted in any of the following:
a)>10 mm Hg increase in IOP from baseline with an absolute IOP > 25 mm Hg
b)required therapy with 3 or more anti-glaucoma medications

10.Pregnancy if child bearing age (confirmed by pregnancy test) and to avoid pregnancy during the 36 weeks of the study. Pregnancy test will not be done in post-menopausal women (defined as 12 months post LMP). Breast feeding women will be excluded.
11.Hypersensitivity to the active substance or to any of the excipients.
12.Inability to provide informed consent

Study & Design

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