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
Overview
- Phase
- Not Applicable
- Intervention
- Lucentis (Ranibizumab)
- Conditions
- Age-Related Macular Degeneration
- Sponsor
- University of Luebeck
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Multifocal-electroretinoram (ERG) and microperimetry are objective criteria to asses retinal function. No information besides visual acuity exist for the development of retinal function during the course of wet AMD during therapy with Lucentis. The aim of our study is to evaluate the value of multifocal-ERG and microperimetry as an sensitive tool and early predictor of recurrence of the disease. The second goal will be to evaluate the neuroprotective effects of an adequate therapy on retinal function using microperimetry and multifocal-ERG during the course of wet AMD.
Investigators
Dr. Matthias Lueke
Dr. med. Matthias Lüke
University of Luebeck
Eligibility Criteria
Inclusion Criteria
- •Male and female patients above 50 years of age
- •wet age-related macular degeneration (AMD)
- •an available follow-up of 12 months
- •written informed consent
- •visual acuity of 0.1 or better
Exclusion Criteria
- •Systemic conditions or treatments
- •history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
- •clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within the last 6 months
- •ventricular tachyarrythmias requiring ongoing treatment
- •History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
- •Clinically significant impaired renal or hepatic function
- •Stroke within 12 month before trial entry.
- •Known serious allergies to the fluorescein dye use in angiography
- •Known contraindications to the components of Lucentis® formulation.
- •Ocular concomitant conditions/ diseases
Arms & Interventions
Lucentis (Ranibizumab)
Intervention: Lucentis (Ranibizumab)
Outcomes
Primary Outcomes
Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.
Time Frame: 12 months
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.
Secondary Outcomes
- to document changes in best corrected visual acuity (BCVA) measured on 4 meters,(12 months)
- to document changes in angiography(12 months)
- to document changes in optical coherence tomography (OCT)(12 months)