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:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT02956759
Eligibility Criteria:
Inclusion Criteria:
* Adults aged \>= 18 years with untreated DR at severe or very severe NPDR stage in either one or both eyes, according to the clinical opinion of the investigator.
* Sufficiently clear ocular media to allow visualization of the retina and retinal photography in either eye.
* Capable of giving informed consent.
Exclusion Criteria:
* DR at later stage of retinopathy than severe or very severe (eg, two or more of the 4-2-1 criteria are met) NPDR in either eye, but a patient may be enrolled if one eye has severe or very severe NPDR and the fellow eye has PRP-treated PDR and has been stable after treatment.
* Clinically significant macular edema in either eye.
* Dense cataracts or other media opacity preventing visualization of the retina in the eye.
* History of previous surgical or laser treatment for DR or other retinal conditions in a study eye, including history of anti-VEGF or corticosteroid injection or focal laser for DME within 6 months, or any history of scleral buckle, vitrectomy or other retinal detachment repair.
* History of other retinal vascular disorders including CRVO, CRAO, BRVO, BRAO in the study eye.
* Previous cataract or glaucoma surgery is specifically allowed if performed ≥ 6 weeks prior to enrollment.
* Pregnancy.
* Severe renal insufficiency treated with hemodialysis treatment, kidney transplant, pancreatic transplant, and intensive insulin therapy initiated within 4 months.
* Nystagmus, unable to cooperate with laser treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02956759
Study Brief:
Protocol Section:
NCT02956759