Diabetic Macular Edema MedDRA version: 9.1 Level: PT Classification code 10038901
Conditions
Interventions
Trade Name: MACUGEN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pegaptanib
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: .3-
Sponsors
IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed