Ranibizumab Short- and Log-term Effects on Retinal Function in wAMD

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Age-Related Macular Degeneration, Retinal Function

Intervention / Treatment
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* Drug: Lucentis (Ranibizumab)


Participation Criteria
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Eligibility Criteria
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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 Active intraocular inflammation (grade trace or above) in either eye Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye History of uveitis in either eye Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, etc.) or intravitreal corticosteroids in either eye within 3 months prior to inclusion Angle block glaucoma Phthisis Intraocular Pressure <10mmHg Macular or retinal dystrophies Compliance/ Administrative Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to inclusion. Patients will be excluded who were younger than 50 years according of the definition of age-related AMD. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. Pregnant or nursing (lactating) women Inability to comply with study or follow-up procedures. Any treatment with an investigational agent in the past 3 months any condition.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lucentis (Ranibizumab)<br> | Drug: Lucentis (Ranibizumab)<br>* Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months. | Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to document changes in best corrected visual acuity (BCVA) measured on 4 meters, | to document changes in best corrected visual acuity (BCVA) measured on 4 meters, | 12 months | 
| to document changes in angiography | to document changes in angiography | 12 months | 
| to document changes in optical coherence tomography (OCT) | to document changes in optical coherence tomography (OCT) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-Related Macular Degeneration, Retinal Function, multifocal-ERG, Electroretinography, microperimetry, Lucentis, Ranibizumab, longterm effects, best corrected visual acuity, BCVA