Retinal DetachmentPhase 4NCT02068625
Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment
A Phase 4 study testing Rasagiline in people with Retinal Detachment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This randomised, double-blind, placebo-controlled clinical trial investigates the neuroprotective effect of rasagiline in patients suffering from a retinal detachment affecting central vision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Rasagiline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2010to 31 Dec 2018
- Phase
- Phase 4
- 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
- Rhegmatogenous retinal detachment
- Central vision affected for less than 72 hours
- Pseudophakic
- Age 18 or over
- Not participating in other clinical trials
- Willing to attend follow-up visits
- Written informed consent
Who cannot join
- Phakic
- Narrow angle glaucoma
- Previous intraocular surgery other than cataract operation
- Retinal disease
- Concurrent treatment with MAO inhibitors
- Pregnancy
Show all 9Show fewer
- Malignant arterial hypertension
- Liver or kidney failure
- Life-threatening or malignant disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ophthalmology, Bern University Hospital
Bern, 3010
About this study
This randomised, double-blind, placebo-controlled clinical trial investigates the neuroprotective effect of rasagiline in patients suffering from a retinal detachment affecting central vision. Based on results from a study in mice suffering from retinal degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the retina and improves visual acuity outcomes after retinal detachment surgery. Rasagiline is a second-generation propargylamine with neuroprotective properties modulating the caspase-dependent pathway of programmed cell death.
Read the detailed description
Background
In previous experimental studies neuroprotection by rasagiline has been shown in rds-mice, a model for slow retinal degeneration. It is known from these experiments that rasagiline specifically delays apoptosis, but also modifies inflammation and autophagy. The bioavailability of the drug in the central nervous system is high, and based on the literature is sufficient in the retina.
In retinal detachments the outer layers of the neurosensory retina are deprived of nutrients and degeneration of the photoreceptors occurs fast. This is particularly relevant in the macular area of the retina where the density of photoreceptors is high, such that visual acuity recovery can be significantly limited by photoreceptor loss.
Objective
To assess the neuroprotective effect of oral rasagiline (1mg daily for 7 days) administered perioperatively in patients undergoing surgical retinal detachment repair for central vision involving retinal detachments.
Methods
In this clinical trial, patients suffering from retinal detachments affecting the fovea get randomly assigned to perioperative oral treatment with either rasagiline (1mg) or placebo once daily for 7 days. Pharmacologic treatment is initiated at the time of hospital admission, usually the day before surgery. The main outcome of the study is visual acuity six months after surgical retinal detachment repair. Structural differences of the neurosensory retina between groups will be analysed by optical coherence tomography, a non-invasive imaging method for retinal pathology.
- Conditions
- Retinal Detachment
- Being tested
- Rasagiline, Placebo
- Keywords
- retinal detachment, rasagiline, optical coherence tomography, visual acuity, neuroprotection, azilect
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RasagilineDrug
Rasagiline 1mg daily orally for 7 days
PlaceboDrug
Oral treatment with placebo for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients getting perioperative oral treatment with rasagiline (1mg daily) for 7 days Receives: Drug: Rasagiline |
| Control | Placebo comparator | Patients getting perioperative oral treatment with placebo for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ETDRS Visual Acuity
Measured: 6 months
Secondary outcomes (2)
Central retinal thickness
Measured by Optical Coherence Tomography (OCT)
Measured: 6 months
Number of patients with side effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startSep 2010
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Persisting recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Wolf, Study chair, Department of Ophthalmology, Bern University HospitalAndreas Ebneter, Principal investigator, Department of Ophthalmology, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068625
- Sponsor's protocol ID
- 178/10
- Other IDs
- 2012DR2022
- Status last verified
- Feb 2019
- First submitted
- 19 Feb 2014
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Eigeldinger-Berthou S, Meier C, Zulliger R, Lecaude S, Enzmann V, Sarra GM. Rasagiline interferes with neurodegeneration in the Prph2/rds mouse. Retina. 2012 Mar;32(3):617-28. doi: 10.1097/IAE.0b013e31821e2070.
PubMed 21878836Youdim MB, Bar Am O, Yogev-Falach M, Weinreb O, Maruyama W, Naoi M, Amit T. Rasagiline: neurodegeneration, neuroprotection, and mitochondrial permeability transition. J Neurosci Res. 2005 Jan 1-15;79(1-2):172-9. doi: 10.1002/jnr.20350.
PubMed 15573406Travis GH. Mechanisms of cell death in the inherited retinal degenerations. Am J Hum Genet. 1998 Mar;62(3):503-8. doi: 10.1086/301772. No abstract available.
PubMed 9497269Cook B, Lewis GP, Fisher SK, Adler R. Apoptotic photoreceptor degeneration in experimental retinal detachment. Invest Ophthalmol Vis Sci. 1995 May;36(6):990-6.
PubMed 7730033Eliash S, Shteter N, Eilam R. Neuroprotective effect of rasagiline, a monoamine oxidase-B inhibitor, on spontaneous cell degeneration in a rat model. J Neural Transm (Vienna). 2005 Aug;112(8):991-1003. doi: 10.1007/s00702-004-0254-4. Epub 2005 Mar 15.
PubMed 15765264
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment
- ClinicalTrials.gov ID
- NCT02068625
- Acronym / sponsor ID
- 178/10
- Conditions
- Retinal Detachment
- Keywords
- retinal detachment, rasagiline, optical coherence tomography, visual acuity, neuroprotection, azilect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Persisting recruitment difficulties
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 21 Feb 2014 (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.
This randomised, double-blind, placebo-controlled clinical trial investigates the neuroprotective effect of rasagiline in patients suffering from a retinal detachment affecting central vision. Based on results from a study in mice suffering from retinal degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the retina and improves visual acuity outcomes after retinal detachment surgery. Rasagiline is a second-generation propargylamine with neuroprotective properties modulating the caspase-dependent pathway of programmed cell death.
Detailed description
Background
In previous experimental studies neuroprotection by rasagiline has been shown in rds-mice, a model for slow retinal degeneration. It is known from these experiments that rasagiline specifically delays apoptosis, but also modifies inflammation and autophagy. The bioavailability of the drug in the central nervous system is high, and based on the literature is sufficient in the retina.
In retinal detachments the outer layers of the neurosensory retina are deprived of nutrients and degeneration of the photoreceptors occurs fast. This is particularly relevant in the macular area of the retina where the density of photoreceptors is high, such that visual acuity recovery can be significantly limited by photoreceptor loss.
Objective
To assess the neuroprotective effect of oral rasagiline (1mg daily for 7 days) administered perioperatively in patients undergoing surgical retinal detachment repair for central vision involving retinal detachments.
Methods
In this clinical trial, patients suffering from retinal detachments affecting the fovea get randomly assigned to perioperative oral treatment with either rasagiline (1mg) or placebo once daily for 7 days. Pharmacologic treatment is initiated at the time of hospital admission, usually the day before surgery. The main outcome of the study is visual acuity six months after surgical retinal detachment repair. Structural differences of the neurosensory retina between groups will be analysed by optical coherence tomography, a non-invasive imaging method for retinal pathology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: RasagilinePatients getting perioperative oral treatment with rasagiline (1mg daily) for 7 days |
| Control | Placebo comparator | Drug: PlaceboPatients getting perioperative oral treatment with placebo for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Rhegmatogenous retinal detachment
- Central vision affected for less than 72 hours
- Pseudophakic
- Age 18 or over
- Not participating in other clinical trials
Key exclusion criteria (9 listed)
- Phakic
- Narrow angle glaucoma
- Previous intraocular surgery other than cataract operation
- Retinal disease
- Concurrent treatment with MAO inhibitors
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 |
|---|---|---|
| RasagilineRasagiline 1mg daily orally for 7 days | Drug | Treatment |
| PlaceboOral treatment with placebo for 7 days | Drug | Control |
Primary outcome
ETDRS Visual Acuity
Time frame: 6 months
2 secondary outcomes
Central retinal thickness
Time frame: 6 months
Number of patients with side effects
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Persisting recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Background: PubMed 21878836Eigeldinger-Berthou S, Meier C, Zulliger R, Lecaude S, Enzmann V, Sarra GM. Rasagiline interferes with neurodegeneration in the Prph2/rds mouse. Retina. 2012 Mar;32(3):617-28. doi: 10.1097/IAE.0b013e31821e2070.
- Background: PubMed 15573406Youdim MB, Bar Am O, Yogev-Falach M, Weinreb O, Maruyama W, Naoi M, Amit T. Rasagiline: neurodegeneration, neuroprotection, and mitochondrial permeability transition. J Neurosci Res. 2005 Jan 1-15;79(1-2):172-9. doi: 10.1002/jnr.20350.
- Background: PubMed 9497269Travis GH. Mechanisms of cell death in the inherited retinal degenerations. Am J Hum Genet. 1998 Mar;62(3):503-8. doi: 10.1086/301772. No abstract available.
- Background: PubMed 7730033Cook B, Lewis GP, Fisher SK, Adler R. Apoptotic photoreceptor degeneration in experimental retinal detachment. Invest Ophthalmol Vis Sci. 1995 May;36(6):990-6.
- Background: PubMed 15765264Eliash S, Shteter N, Eilam R. Neuroprotective effect of rasagiline, a monoamine oxidase-B inhibitor, on spontaneous cell degeneration in a rat model. J Neural Transm (Vienna). 2005 Aug;112(8):991-1003. doi: 10.1007/s00702-004-0254-4. Epub 2005 Mar 15.
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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.
Sebastian Wolf study chair
Department of Ophthalmology, Bern University Hospital
Andreas Ebneter principal investigator
Department of Ophthalmology, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rasagiline in people with Retinal Detachment, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 Feb 2019. 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Persisting recruitment difficulties). Results are not available in the source record.
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?
ETDRS Visual Acuity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02068625, which also lists 5 linked publications.
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 20 Feb 2019.