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

NCT01947881 | Completed

• 1 other identifier: 4C-2013-05
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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

Keywords

Diabetic Macular Edema; anti-VEGF; Treatment Response

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Best Corrected Visual Acuity (BCVA) (Change from screening)

  Change from Screening at 3 Months

• Central Retinal Thickness (change from screening)

  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

Study Arms (1)

Patients with DME

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Coimbra, 3000-548, Portugal

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 23, 2013
• Study Start: January 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

PT (1)