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

NCT ID: NCT01947881

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Diabetic Macular Edema

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with DME

Patients with DME who need treatment with anti-VEGF injections of Lucentis.

No interventions assigned to this group

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association for Innovation and Biomedical Research on Light and Image

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

Coimbra, , Portugal

Countries

Portugal

Other Identifiers

4C-2013-05

Identifier Type: -

Identifier Source: org_study_id