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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Portugal
  • Coimbra, Portugal, 3000-548
    • Centre for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diabetic Type 2 patients with clinically significant Diabetic Macular Edema with therapeutic indication for treatment with intravitreal injections of anti-VEGF Lucentis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with DME; Patients with DME who need treatment with anti-VEGF injections of Lucentis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Retinal Thickness (Change from screening)	Measured by Spectral Domain Optical Coherence Tomography (OCT)	Change from Screening at 3 Months
Presence of OCT diffuse macular edema (without cyst formation) (change from screening)		Change from Screening at 3 Months
Presence of neurosensorial retinal detachment. (change from screening)		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)		Change from Screening at 3 Months
Presence and extension of capillary occlusion (change from screening)		Change from Screening at 3 Months
Area of macular leakage (intraretinal fluid volume and retinal thickness) (change frmo screening)		Change from Screening at 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity (BCVA) (Change from screening)		Change from Screening at 3 Months
Central Retinal Thickness (change from screening)	Measured by Spectral Domain Optical Coherence Tomography (OCT)	Change from Screening at 6 Months
Presence (and location) of cysts in the retinal layers (change from screening)		Change from Screening at 6 Months
Presence of OCT diffuse macular edema (without cyst formation) (change from screening)		Change from Screening at 6 months
Presence of neurosensorial retinal detachment. (change from screening)		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)		Change from Screening at 6 months
Presence and extension of capillary occlusion (change from screening)		Change from Screening at 6 Months
Area of macular leakage (intraretinal fluid volume and retinal thickness) (change from screening)		Change from Screening at 6 Months
Best Corrected Visual Acuity (change from screening)		Change from Screening at 6 Months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 18, 2013
• First Posted (Estimate): September 23, 2013

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: anti-VEGF; Diabetic Macular Edema; Treatment Response
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: 4C-2013-05