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
- Conditions
- Medical condition: moderate to severe non-proliferative retinopathy with diabetic cystoid macular edema.MedDRA version: 9.1Level: LLTClassification code 10012689Term: Diabetic retinopathy
- Registration Number
- EUCTR2009-009909-25-DE
- Lead Sponsor
- Johann Wolfgang Goethe-Universität Frankfurt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary objectives: evaluation of improvement for the best-corrected visual acuity (BCVA)<br>measured by EDTRS charts;Secondary Objective: Secondary objectives:<br>evaluation of the development of retinal thickness, ocular neovascularization, <br>change in visual quality (objective and subjective) and evaluation of Adverse Events.<br>;Primary end point(s): Development of the best corrected visual acuity (according to EDTRS) after 56 weeks<br>Change in retinal thickness, ocular neovasculation and visual quality
- Secondary Outcome Measures
Name Time Method