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

Phase 1

• Conditions: Retinal function in patients with wet age-related macular degeneration; MedDRA version: 12.1Level: LLTClassification code 10067791Term: Wet macular degeneration

• Registration Number: EUCTR2010-021777-37-DE
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein (UK-SH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-09
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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
2.Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
3. History of uveitis in either eye
4.Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, etc.) or intravitreal corticosteroids in either eye within 3 months prior to inclusion
5.Angle block glaucoma
6.Phthisis
7.Intraocular Pressure <10mmHg
8.Macular or retinal dystrophies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months. ;Secondary Objective: Secondary objectives are <br>•to document changes in best corrected visual acuity (BCVA) measured on 4 meters,<br>•to document changes in angiography<br>•to document changes in optical coherence tomography (OCT) <br>;Primary end point(s): Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.