Clinical trial NCT01947881: Characterization of Eyes With Diabetic Macular Edema That Show Different Treatment Response to Intravitreal Anti-VEGF (CHARTRES)
Official title: Characterization of Eyes With Diabetic Macular Edema That Show Different Treatment Response to Intravitreal Anti-VEGF (CHARTRES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema
anti-VEGF
Treatment Response
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 71
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Central Retinal Thickness (Change from screening)
timeFrame: Change from Screening at 3 Months
measure: Presence of OCT diffuse macular edema (without cyst formation) (change from screening)
timeFrame: Change from Screening at 3 Months
measure: Presence of neurosensorial retinal detachment. (change from screening)
timeFrame: Change from Screening at 3 Months
measure: Degree of integrity of the photoreceptors in the inner/outer segments layer in the 1 mm centered in the fovea (change from screening)
timeFrame: Change from Screening at 3 Months
measure: Presence and extension of capillary occlusion (change from screening)
timeFrame: Change from Screening at 3 Months
measure: Area of macular leakage (intraretinal fluid volume and retinal thickness) (change frmo screening)
timeFrame: Change from Screening at 3 Months
Secondary outcomes:
measure: Best Corrected Visual Acuity (BCVA) (Change from screening)
timeFrame: Change from Screening at 3 Months
measure: Central Retinal Thickness (change from screening)
timeFrame: Change from Screening at 6 Months
measure: Presence (and location) of cysts in the retinal layers (change from screening)
timeFrame: Change from Screening at 6 Months
measure: Presence of OCT diffuse macular edema (without cyst formation) (change from screening)
timeFrame: Change from Screening at 6 months
measure: Presence of neurosensorial retinal detachment. (change from screening)
timeFrame: Change from Screening at 6 Months
measure: Degree of integrity of the photoreceptors in the inner/outer segments layer in the 1 mm centered in the fovea (change from screening)
timeFrame: Change from Screening at 6 months
measure: Presence and extension of capillary occlusion (change from screening)
timeFrame: Change from Screening at 6 Months
measure: Area of macular leakage (intraretinal fluid volume and retinal thickness) (change from screening)
timeFrame: Change from Screening at 6 Months
measure: Best Corrected Visual Acuity (change from screening)
timeFrame: Change from Screening at 6 Months
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Centre for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
Study officials:
References: