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

Not Applicable

Completed

• Conditions: Age-Related Macular Degeneration; Retinal Function
• Interventions: Drug: Lucentis (Ranibizumab)

• Registration Number: NCT01269151
• Lead Sponsor: University of Luebeck

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-01-03
• Study First Submitted QC: 2011-01-03
• Study First Posted: 2011-01-04
• Primary Completion: 2013-03
• Study Completion: 2014-04
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male and female patients above 50 years of age
2. wet age-related macular degeneration (AMD)
3. an available follow-up of 12 months
4. written informed consent
5. visual acuity of 0.1 or better

Exclusion Criteria

Systemic conditions or treatments

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 within the last 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

Compliance/ Administrative

1. 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.
2. Patients will be excluded who were younger than 50 years according of the definition of age-related AMD.
3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
4. Pregnant or nursing (lactating) women
5. Inability to comply with study or follow-up procedures.
6. Any treatment with an investigational agent in the past 3 months any condition.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lucentis (Ranibizumab)	Lucentis (Ranibizumab)	-

Primary Outcome Measures

Name	Time	Method
Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.	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 Outcome Measures

Name	Time	Method
to document changes in best corrected visual acuity (BCVA) measured on 4 meters,	12 months	to document changes in best corrected visual acuity (BCVA) measured on 4 meters,
to document changes in angiography	12 months	to document changes in angiography
to document changes in optical coherence tomography (OCT)	12 months	to document changes in optical coherence tomography (OCT)

Trial Locations

Locations (1)

University of Luebeck - Department of Ophthalmology; 🇩🇪 Lübeck, Germany