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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Diabetic Macular Edema

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with DME<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Macular Edema, anti-VEGF, Treatment Response