NCT01269151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

2.4 years

First QC Date

January 3, 2011

Last Update Submit

April 7, 2015

Conditions

Age-Related Macular DegenerationRetinal Function

Keywords

Age-Related Macular DegenerationRetinal Functionmultifocal-ERGElectroretinographymicroperimetryLucentisRanibizumablongterm effectsbest corrected visual acuityBCVA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

Lucentis (Ranibizumab)

EXPERIMENTAL
Drug: Lucentis (Ranibizumab)

Interventions

Lucentis (Ranibizumab)DRUG

Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry

Lucentis (Ranibizumab)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Angle block glaucoma
  • Phthisis
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Luebeck - Department of Ophthalmology

Lübeck, 23538, Germany

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Salvatore Grisanti, M.D. Prof.

    University of Luebeck - Department of Ophthalmology: Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Matthias Lüke

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 4, 2011

Study Start

October 1, 2010

Primary Completion

March 1, 2013

Study Completion

April 1, 2014

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

DE(1)