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:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT02309502
Eligibility Criteria:
Inclusion Criteria:
Patient-eligibility
Inclusion criteria:
1. Older than 18 years of age
2. Male or female patients with diabetes mellitus type I or type 2 who meet the WHO or ADA criteria for diabetes
3. Able to give informed consent
Study Eye eligibility
Inclusion criteria:
1. Treatment-naive S-NPDR
2. ETDRS visual acuity equivalent to 35 letters or better (Snellen equivalent 6/60 or better)
3. Any of the following:
* Extensive (\>20) intraretinal hemorrhages in each of 4 quadrants
* Definite venous beading in 2+ quadrants
* Prominent IRMA in 1+ quadrant
4. Mean central retinal thickness of less than or equal to 300 microns as measured by Deep Range Imaging Optical Coherence Tomography (DRI -OCT) scans
5. No intra-retinal fluid (IRF) or sub-retinal fluid (SRF) on DRI-OCT
6. Adequate pupil dilatation and clear media to perform wide-field colour, red-free imaging and fundus fluorescein angiography (WF-FFA), wide-field fundus autofluorescence imaging (WF-AF), DRI-OCT of retina and choroid, Multispectral Imaging (MSI) of chorioretinal oxygenation and P-RPhS
7. Ability to perform accurate Humphrey visual field test
Exclusion Criteria:
Patient-eligibility
Exclusion criteria:
1. History of chronic renal failure or renal transplant for diabetic nephropathy
2. Recent (last 6 months) or on-going poor glycaemic control. H1Ac greater than 10.0mg/dL
3. Creatinine greater than 1.2 mg/dL
4. HDL equal to or greater than 40 mg/dL
5. Uncontrolled hypertension. Blood pressure greater or equal to 180/110 mmHg
6. Patient is unavailable for follow-up visits
7. Pregnant women or breast-feeding females
Study Eye eligibility
Exclusion criteria:
1. Lens opacity that could influence vision and results
2. Any surgical or non-retinal laser treatment to the study eye within 2 months
3. Narrow drainage angles with raised intraocular pressure and angle closure glaucoma.
4. Planned YAG peripheral iridotomy
5. Previous retinal laser photocoagulation, intraocular drug therapy, or macular laser treatment to treatment eye in last year
6. Any previous ocular condition that may be associated with a risk of macular oedema
7. Active lid or adnexal infection
8. Planned intra-ocular surgery within one year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02309502
Study Brief:
Protocol Section:
NCT02309502