EUCTR2010-021777-37-DE
Active, not recruiting
Phase 1
A prospective, non-randomized, mono-center, cohort study to evaluate the short- and long-term effects of 0.5mg intraocular Ranibizumab (Lucentis) injections on retinal function in patients with wet age-related macular degeneration during twelve month - Ranibizumab short- and long-term effects on retinal function in wAMD
niversitätsklinikum Schleswig-Holstein (UK-SH)0 sites20 target enrollmentAugust 9, 2010
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Retinal function in patients with wet age-related macular degeneration
- Sponsor
- niversitätsklinikum Schleswig-Holstein (UK-SH)
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.wet age\-related macular degeneration (AMD)
- •2\.an available follow\-up of 12 months
- •3\. written informed consent
- •4\. visual acuity of 0\.1 or better
- •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
- •1\.history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
- •2\.clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
- •3\. ventricular tachyarrythmias requiring ongoing treatment
- •4\.History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
- •5\.Clinically significant impaired renal or hepatic function
- •6\. Stroke within 12 month before trial entry.
- •7\.Known serious allergies to the fluorescein dye use in angiography
- •8\.Known contraindications to the components of Lucentis® formulation.
- •Ocular concomitant conditions/ diseases
- •1\.Active intraocular inflammation (grade trace or above) in either eye
Outcomes
Primary Outcomes
Not specified
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