Age-Related Macular DegenerationNCT01638858
Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)
A study testing Lucentis (Ranibizumab) in people with Age-Related Macular Degeneration, run by University of Luebeck at 1 site in Germany.
Trial summary
In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Lucentis (Ranibizumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetic macular edema with center involvement in at least one eye
- patients with a central retinal thickness
- patients with a BCVA of 78-24 EDTRS letters
- decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
- Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
Who cannot join
- history or evidence of severe cardiac disease
- clinical or medical history uncontrolled hypertension or diabetes
- of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
- ventricular tachyarrhythmias requiring ongoing treatment
- history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation
- clinically significant impaired renal or hepatic function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-randomized, Mono-center, Cohort Study of Evaluate the Effects of 0.5mg Intraocular Ranibizumab (Lucentis)Injections on Retinal Function in Patients With Diabetic Macular Edema (DME) During Twelve Months
In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Lucentis (Ranibizumab)
- 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.
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
Measured: 12 months
Secondary outcomes (3)
to document changes in best corrected visual acuity measured on 4 meters
to document changes in best corrected visual acuity measured on 4 meters
Measured: 12 months
to document changes in microperimetry
to document changes in microperimetry
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 posted12 Jul 2012 (estimated)
- Study startOct 2011
- Primary completionJul 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT01638858
- Sponsor's protocol ID
- Lucentis_DME_ERG
- Other IDs
- 2011-002202-70
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2012
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Mono-center, Cohort Study of Evaluate the Effects of 0.5mg Intraocular Ranibizumab (Lucentis)Injections on Retinal Function in Patients With Diabetic Macular Edema (DME) During Twelve Months
- ClinicalTrials.gov ID
- NCT01638858
- Acronym / sponsor ID
- Lucentis_DME_ERG
- Conditions
- Age-Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2014 (actual)
- First posted
- 12 Jul 2012 (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.
In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- 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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diabetic macular edema with center involvement in at least one eye
- patients with a central retinal thickness
- patients with a BCVA of 78-24 EDTRS letters
- decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
- Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
Key exclusion criteria (6 listed)
- history or evidence of severe cardiac disease
- clinical or medical history uncontrolled hypertension or diabetes
- of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
- ventricular tachyarrhythmias requiring ongoing treatment
- history or evidence clinically significant peripheral vascular disease, such a 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
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
Time frame: 12 months
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
3 secondary outcomes
to document changes in best corrected visual acuity measured on 4 meters
Time frame: 12 months
to document changes in microperimetry
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 Jul 2014.
- Link Text: University of Lübeck - 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, 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 6 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 Jul 2014. 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?
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG 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 Jul 2014.