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Diabetic Macular Edema | Characterization of Eyes With Diabetic Macular Edema That Show Different Treatment Response to Intravitreal Anti-VEGF (CHARTRES)

Diabetic Macular Edema research study

What is the primary objective of this study?

The purpose of this study is to identify Diabetic Macular Edema (DME) characteristics in eyes that show different response to treatment with anti-VEGF (vascular endothelial growth factor) injections of Lucentis.

Who is eligible to participate?

Inclusion Criteria: - Patients with 40 years of age or older. - Type 2 Diabetes Mellitus. - Glycosylated hemoglobin (HbA1C) ≤ 12% at screening visit. - Presence of clinically significant DME involving the center (fovea) diagnosed in at least one eye that is eligible for anti-VEGF treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at screening visit, will be selected as the study eye. - Visual impairment due to DME with BCVA ≥ 39 letters and ≤ 73 letters (≥ 20/160 and ≤ 20/40). - Central subfield thickness ≥ 300µm. Exclusion Criteria: - Presence of any other ocular disease than DME in the study eye that may confound study results, such as Proliferative Retinopathy. - Previous treatment with vitrectomy or intravitreous injections of triancinolone or anti-VEGF drugs in the study eye. - Any previous laser photocoagulation (panretinal or focal) in the study eye within 6 months prior to inclusion in this study. - Active intraocular inflammation (grade trace or above) in either eye at screening visit. - Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at screening visit. - Important refractive errors (myopia > 6D) or opacification of clear media that interferes with images evaluation. - Patients with renal failure or other systemic conditions which, in the opinion of the investigator, would preclude schedule study visits, completion of the study or a safe administration of study medication. - Other criteria that in the opinion of the investigator should condition the evaluation purposed.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Diabetic Macular Edema

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Patients with DMEPatients with DME who need treatment with anti-VEGF injections of Lucentis.

Study Status

Completed

Start Date: January 2014

Completed Date: October 2015

Phase:

Type: Observational

Design:

Primary Outcome: Central Retinal Thickness (Change from screening)

Secondary Outcome: Best Corrected Visual Acuity (BCVA) (Change from screening)

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01947881

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