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Clinical Trials/EUCTR2009-014444-11-IT
EUCTR2009-014444-11-IT
Active, not recruiting
Not Applicable

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

IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS0 sitesNovember 17, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Macular Edema
Sponsor
IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS
Status
Active, not recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 17, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS

Eligibility 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

  • \-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

Outcomes

Primary Outcomes

Not specified

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