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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT02348918
Eligibility Criteria:
Inclusion Criteria:
* Male or female, 18 years of age or older.
* Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT
* Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.
* Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.
* In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.
* Intra-Ocular Pressure (IOP) is under control (i.e., IOP
≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops.
* Willing and able to return for all study visits.
* Able to meet the extensive post-op evaluation regimen.
* Understands and signs the informed consent form.
Exclusion Criteria:
* Active proliferative diabetic retinopathy (PDR) in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma.
* Uncontrolled hypertension defined as systolic \>180 mmHg or \> 160 mmHg on 2 consecutive measurements or diastolic \> 100 mmHg on optimal medical regimen
* Screening HgA1c blood test \> 10.0
* Focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment.
* A history of intravitreal anti-VEGF injection of any type in the study eye within the last 45 days prior to study enrollment.
* History of rhegmatogenous retinal detachment, retinal tear(s), or traction retinal detachments in the study eye.
* Epiretinal membrane and/or vitreomacular traction in the study eye as determined by the central reading center.
* Previous pars plana vitrectomy in the study eye
* Any intraocular surgery in the study eye within the last 90 days prior to study enrollment.
* YAG laser treatment in the study eye in last 30 days prior to study enrollment.
* High myopia in the study eye, with a spherical equivalent of \>8.00D at screening
* Other ocular pathologies that in the investigator's opinion would interfere with the subject's vision in the study eye.
* Chronic or recurrent uveitis.
* Ongoing ocular infection or inflammation in either eye.
* A history of cataract surgery complications/vitreous loss in the study eye.
* Congenital eye malformations in the study eye.
* A history of penetrating ocular trauma in the study eye.
* Mentally handicapped.
* Pregnant female, as determined for women less than 60 years old by a positive urine pregnancy test during the screening window.
* Nursing female.
* Currently participating in any other clinical research study.
* Contraindication to the study medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02348918
Study Brief:
Protocol Section:
NCT02348918