Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT01223612
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield ≥ 300 microns
* Best corrected visual acuity in the study eye between 55 and 79 ETDRS letters at 1 metre (Snellen equivalent ≥ 6/24 and ≤ 6/9)
* Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
* Intraocular pressure less than 30 mmHg
* Ability to return for study visits
* Visual acuity in fellow eye ≥ 2/60
* Fellow eye has received no anti-VEGF treatment within the past 3 months and no expectation of such treatment in next 12 months
* No previous laser within 3 months of randomisation
* Ability to give informed consent throughout the duration of the study
Exclusion Criteria:
* Macular ischaemia
* Macular oedema from a cause other than diabetic macular oedema
* Co-existent ocular disease
* Presence of an ocular condition such that visual acuity would not improve from resolution of macular oedema
* Presence of an ocular condition that might affect macular oedema or alter visual acuity during the course of the study
* A substantial cataract that is likely to be decreasing visual acuity by 3 lines or more
* History of treatment for diabetic macular oedema at any time in the past 3 months
* History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation
* Anticipated need for PRP in the 6 months following randomisation.
* Proliferative diabetic retinopathy in the study eye.
* A condition that, in the opinion of the investigator, would preclude participation in the study.
* Haemoglobin A1c \> 11.0 %
* A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
* Blood pressure \>170/100 mmHg
* Myocardial infarction, other cardiac event requiring hospitalisation, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 6 months prior to randomisation
* Major surgery within 28 days prior to randomisation or major surgery planned during the next 12 months at baseline
* 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
* Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation
* Pregnant or lactating women or women intending to become pregnant within the study period including 3 months after study cessation
* History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery) within prior 3 months or anticipated within the next 6 months following randomisation.
* Aphakia
* Uncontrolled glaucoma
* External ocular infection, including conjunctivitis, chalazion, or severe blepharitis
* Known allergy to fluorescein dye or to any component of the study drug
* Fertile male unwilling to use contraception for the duration of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01223612
Study Brief:
Protocol Section:
NCT01223612