A Prospective Randomised Controlled Trial of Intravitreal Ozurdex and Macular Laser Therapy versus Macular Laser Therapy only in Diabetic Macular Oedema (OZLASE study)

Phase 1

• Conditions: Diabetic macular oedema; MedDRA version: 14.0Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2011-003339-74-GB
• Lead Sponsor: Moorfields Eye Hospital R&D Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-17
• Study Completion: 2013-10-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

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 considered 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 54 and 78 letters at 1m (ie Snellen VA 6/24 - 6/9) at baseline. 4.On clinical exam, retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield > 300 microns (Spectralis) at baseline. The diabetic macular oedema must be mild to moderate defined as centre involving with a visual acuity of 6/24 - 6/). 5.Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs. 6.Intraocular pressure less than 30 mmHg. 7.Ability to return for study visits 8.Visual acuity in fellow eye = 2/60 9. Ability to give informed consent throughout the duration of the study 10. Previous laser treatment to the macula is not a contraindication to inclusion in 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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 membrane) 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 at any time in the past 3 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment) in the study eye. 7.History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation in the study eye. 8.Anticipated need for PRP in the 6 months following randomisation in the study eye. 9.Proliferative diabetic retinopathy in the study eye. 10.A condition that, in the opinion of the investigator, would preclude participation in the study. 11.Haemoglobin A1c > 11.0 % 12.A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant 13.Blood pressure >170/100 mmHg (i.e. systolic above 170 or diastolic above 100). If blood pressure is brought below 170/100 by anti-hypertensive treatment, subject can become eligible. 14.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. 15.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. 16.Pregnant or lactating women or women intending to become pregnant within the study period including 3 months after study cessation. 17.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. 18.Aphakia 19.Uncontrolled glaucoma (in investigator’s judgment). 20.Exam evidence of external ocular infection, including conjunctivitis, chalazion, or severe bl

Study & Design

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