A Multicentre Prospective Open-label Randomised Clinical Trial Comparing the Efficacy of Fixed versus Variable dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) in patients with refractory diabetic macular oedema.

Phase 1

• Conditions: Diabetic macular oedema; MedDRA version: 14.1 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-003661-17-GB
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-24
• Study Completion: 2014-11-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Subjects of either sex aged 18 years or over
2. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considere to be sufficient evidence that diabetes is present:
i. Current regular use of insulin for the treatment of diabetes
ii. Current regular use of oral anti-hyperglycaemic agents for the treatment of diabetes
iii. Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for Diagnosis of Diabetes)
3.Best corrected visual acuity in the study eye between =34 and =73 ETDRS letters at 1m at baseline attributable to DMO.
4.On clinical exam at baseline in the study eye, retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield > 300 microns (Spectralis) despite previous therapy.
5. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.
6. Ability to return for study visits
7. Visual acuity in fellow eye = 2/60
8. Ability to give informed consent throughout the duration of the study

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

The following exclusions apply to the study eye only (i.e. they may be present for the non study eye, provided that inclusion criterion 8 is met):
1.Macular ischaemia (FAZ > 1000µm in diameter or severe perifoveal intercapillary loss on IVFA).
2.Macular oedema is considered to be due to a cause other than diabetic macular oedema. An eye should not be considered eligible if: (1) the macular oedema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal embrane) is the primary cause of the macular oedema.
3.Co-existent ocular disease: An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular oedema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non retinal conditions, such as amblyopia).
4.An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study (e.g. vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, etc).
5.A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 6/12 or worse if eye was otherwise normal).
6.History of treatment for DMO with peribulbar or intravitreal steroids in the study eye in the past 6 months.
7. History of macular laser in study eye in the last 3 months.
8. History of antiVEGF therapy within the last 1 month.
9. Active proliferative diabetic retinopathy or rubeosis in the study eye at baseline. (Stable and treated proliferative diabetic retinopathy may be included).
10. A condition that, in the opinion of the investigator, would preclude participation in the study.
11. A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
12.. Major surgery within 28 days prior to randomisation or major surgery planned during the next 12 months at baseline. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
13. Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug that has not received regulatory approval at the time of study entry. Note: subjects cannot receive another investigational drug while participating in the study.
14. Pregnant or lactating women or women intending to become pregnant within the study period.
15. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following randomisation.
16. Aphakia
17. A diagnosis of glaucoma which in the opinion of a glaucoma specialist is at high risk of progression or ocular hypertension requiring at least one topical medication.

Study & Design

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