Diabetes With Diabetic Retinopathy With Macular Edema Clinical Trial
— ICV-DMEOfficial title:
International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients - the ICV-DME Study
| NCT number | NCT02639507 |
| Other study ID # | 14-008884 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2015 |
| Est. completion date | March 2020 |
| Verified date | March 2020 |
| Source | Mayo Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | March 2020 |
| Est. primary completion date | March 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mayo Clinic Florida | Jacksonville | Florida |
| United States | Mayo Clinic in Florida | Jacksonville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Mayo Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity | 6 months |