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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Medical condition: moderate to severe non-proliferative retinopathy with diabetic cystoid macular edema.
Sponsor: Johann Wolfgang Goethe-Universität Frankfurt
Enrollment: 120
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

March 17, 2009

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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