Age-Related Macular DegenerationLucERGNCT01269151
Ranibizumab Short- and Log-term Effects on Retinal Function in wAMD
A study testing Lucentis (Ranibizumab) in people with Age-Related Macular Degeneration and Retinal Function, run by University of Luebeck at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Retinal Function
- What is being tested?
- Lucentis (Ranibizumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Luebeck - Department of Ophthalmology
Lübeck, 23538
About this study
Official title: 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
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.
- Conditions
- Age-Related Macular Degeneration, Retinal Function
- Being tested
- Lucentis (Ranibizumab)
- Keywords
- Age-Related Macular Degeneration, Retinal Function, multifocal-ERG, Electroretinography, microperimetry, Lucentis, Ranibizumab, longterm effects, best corrected visual acuity, BCVA
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lucentis (Ranibizumab)Drug
Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry
| Study group | Role | What they receive |
|---|---|---|
| Lucentis (Ranibizumab) | Experimental | Not described Receives: Drug: Lucentis (Ranibizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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,
Measured: 12 months
to document changes in angiography
to document changes in angiography
Measured: 12 months
to document changes in optical coherence tomography (OCT)
to document changes in optical coherence tomography (OCT)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Matthias Lueke, University of Luebeck
- Investigators
- Salvatore Grisanti, M.D. Prof., Principal investigator, University of Luebeck - Department of Ophthalmology: Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269151
- Sponsor's protocol ID
- LucERG-001
- Acronym
- LucERG
- Status last verified
- Apr 2015
- First submitted
- 3 Jan 2011
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01269151
- Acronym / sponsor ID
- LucERG / LucERG-001
- Conditions
- Age-Related Macular Degeneration, Retinal Function
- Keywords
- Age-Related Macular Degeneration, Retinal Function, multifocal-ERG, Electroretinography, microperimetry, Lucentis, Ranibizumab, longterm effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lucentis (Ranibizumab) | Experimental | Drug: Lucentis (Ranibizumab) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lucentis (Ranibizumab)Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry | Drug | Lucentis (Ranibizumab) |
Primary outcome
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.
3 secondary outcomes
to document changes in best corrected visual acuity (BCVA) measured on 4 meters,
Time frame: 12 months
to document changes in angiography
Time frame: 12 months
to document changes in optical coherence tomography (OCT)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- University of Luebeck - Department of Ophthalmology - GermanyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Grisanti, M.D. Prof. principal investigator
University of Luebeck - Department of Ophthalmology: Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lucentis (Ranibizumab) in people with Age-Related Macular Degeneration and Retinal Function, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.