Functional and morphological retinal changes in diabetic macular edema treated with pegaptanib - Pegaptanib in diabetic macular edema

• Conditions: Diabetic Macular Edema; MedDRA version: 9.1Level: PTClassification code 10038901

• Registration Number: EUCTR2009-014444-11-IT
• Lead Sponsor: IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Clinically significant diabetic macular edema evaluated with OCT and FA -VA with ETDRS letters score ranged between 68 and 25 letters in the study eye (20/50-20/320) -Laser photocoagulation in the study eye already performed or that can be withheld for at least 3 months after enrollment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-patients with uncontrolled systemic (as diabetes HbA1c >10%) or ocular diseases -any history of any intraocular surgery in the study eye within the past 6 months preceding screening -previous intravitreal injections -glaucoma or ocular hypertension not well controlled with hypotensive therapy -presence of iris neovascularization -significant dioptric means opacities -high risk or proliferant diabetic retinopathy -myopia >8 D

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study aims to assess functional and structural retinal changes in patients with diabetic macular edema (DME) treated with intravitreal Pegaptanib 0.3 mg.;Secondary Objective: Secondary endpoints included stabilization and/or improvement of VA (number of ETDRS letters), of fixation stability, and reduction of macular thickness.;Primary end point(s): The primary endpoint of the study is represented by a stabilization and/or improvement of MP1 and mfERG retinal sensitivities at 6 and 12 months from baseline.