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

Diabetic Macular Edema Clinical Trial

— CHARTRES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947881
• Other study ID #: 4C-2013-05
• Status: Completed
• Phase: N/A
• First received: September 17, 2013
• Last updated: March 9, 2017
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: March 2017
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Locations

Country	Name	City	State
Portugal	Centre for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image	Coimbra

Sponsors (1)

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

Country where clinical trial is conducted

Portugal, 

Outcome

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