Clinical trial NCT02639507: International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients
Official title: International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients - the ICV-DME Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes With Diabetic Retinopathy With Macular Edema
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will have the following characteristics:

* Background diabetic retinopathy.
* Center involving macular edema with CST \> 325 µm as measured by SD-OCT.
* Predominantly intact (80%) ELM and IS/OS lines within 500 µm of the fovea on both horizontal and vertical SD-OCT scans.
* Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive

Brief summary: The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic retinopathy is often treated with laser or injections of medicine in to the eye.


Eligibility criteria: Inclusion Criteria:

* Men and women, \> 18 years of age with type 1 or 2 diabetes mellitus diagnosed and treated by an endocrinologist, internist or family medicine physician
* Background diabetic retinopathy
* DME with central subfield thickness (CST) \> 325 µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
* HbA1c level of \< 10.0 mg/dl
* Previous cataract surgery with implantation of a stable posterior chamber intraocular lens or a phakic eye with 1+ (out of 4+ scale) or less lens opacification
* Predominantly intact (80%) external limiting membrane (ELM) and photoreceptor inner/outer segment (IS/OS) lines within 500 µm of the fovea on horizontal and vertical SD-OCT scans
* Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive.

Exclusion Criteria:

* Intraocular anti-vascular endothelial growth factor (VEGF) injection within the previous 3 months
* Systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy within the previous 3 months
* Intraocular corticosteroid injection within the previous 6 months
* Peri-ocular corticosteroid injection within the previous 3 months
* Vitreomacular traction on SD-OCT scan (epiretinal membrane is allowed)
* Previous anterior or pars plana vitrectomy
* Glaucoma (IOP of \> 21 mmHg or regular use of more than 2 IOP lowering drugs)
* Previous trabeculectomy
* Likelihood of needing intraocular surgery within 6 months
* Hard exudates involving the fovea
* Proliferative diabetic retinopathy with any evidence of retinal traction
* Cataract of grade 2+ or greater.

Primary outcomes:
measure: average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michael W Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References: