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Clinical Trials/EUCTR2009-009909-25-DE
EUCTR2009-009909-25-DEActive, not recruitingNot Applicable

Evaluation of the efficacy and safety of a Macugen monotherapy versus Combined Therapies in the Treatment of Diabetic Retinopathy – a single centre, randomized, prospective Phase II trial

Johann Wolfgang Goethe-Universität Frankfurt0 sites120 target enrollmentStarted: March 17, 2009Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
120

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • age over 18 years of either gender, moderate to severe non proliferative diabetic retinopathy (NPDR) with diabetic cystoid macular edema, informed consent given
  • 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

  • History of any retinal laser- or kryokoagulation, any intravitreal anti-VEGF, steroid or (core)-vitrectomy within the last 6 months, vitreoretinal traction syndrome, Myopia of >8 diopters, axial length of >26mm, and likelihood of requiring cataract surgery within the ensuing 10 months. Any history of active ocular or periocular infection, radiation to head, neck, or eye; Glycosylated hemoglobin (GHb) levels of >13%; >3 episodes of severe hypoglycemia within 3 months of study entry; >2 episodes of ketoacidosis within 1 year of baseline; or evidence of severe cardiac disease, any disease that makes it impossible to conduct the trial with the patient, pregnancy and lactation, participating in a clinical trial within the last 4 weeks, patients that cannot give informed consent themself, all contra indications for the test drugs

Investigators

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