Overview

This trial is active, not recruiting.

Condition diabetic macular edema
Sponsor Association for Innovation and Biomedical Research on Light and Image
Start date January 2014
End date February 2015
Trial size 70 participants
Trial identifier NCT01947881, 4C-2013-05

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with DME who need treatment with anti-VEGF injections of Lucentis.

Primary Outcomes

Measure
Central Retinal Thickness (Change from screening)
time frame: Change from Screening at 3 Months
Presence (and location) of cysts in the retinal layers (change from screening)
time frame: Change from Screening at 3 Months
Presence of OCT diffuse macular edema (without cyst formation) (change from screening)
time frame: Change from Screening at 3 Months
Presence of neurosensorial retinal detachment. (change from screening)
time frame: Change from Screening at 3 Months
Degree of integrity of the photoreceptors in the inner/outer segments layer in the 1 mm centered in the fovea (change from screening)
time frame: Change from Screening at 3 Months
Presence and extension of capillary occlusion (change from screening)
time frame: Change from Screening at 3 Months
Area of macular leakage (intraretinal fluid volume and retinal thickness) (change frmo screening)
time frame: Change from Screening at 3 Months

Secondary Outcomes

Measure
Best Corrected Visual Acuity (BCVA) (Change from screening)
time frame: Change from Screening at 3 Months
Central Retinal Thickness (change from screening)
time frame: Change from Screening at 6 Months
Presence (and location) of cysts in the retinal layers (change from screening)
time frame: Change from Screening at 6 Months
Presence of OCT diffuse macular edema (without cyst formation) (change from screening)
time frame: Change from Screening at 6 months
Presence of neurosensorial retinal detachment. (change from screening)
time frame: Change from Screening at 6 Months
Degree of integrity of the photoreceptors in the inner/outer segments layer in the 1 mm centered in the fovea (change from screening)
time frame: Change from Screening at 6 months
Presence and extension of capillary occlusion (change from screening)
time frame: Change from Screening at 6 Months
Area of macular leakage (intraretinal fluid volume and retinal thickness) (change from screening)
time frame: Change from Screening at 6 Months
Best Corrected Visual Acuity (change from screening)
time frame: Change from Screening at 6 Months

Eligibility Criteria

Male or female participants at least 40 years old.

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.

Additional Information

Official title Characterization of Eyes With Diabetic Macular Edema That Show Different Treatment Response to Intravitreal Anti-VEGF (CHARTRES)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Association for Innovation and Biomedical Research on Light and Image.