Epiretinal MembraneLERMNCT01238393
Treatment of Epiretinal Membranes With Ranibizumab
A study testing intravitreal ranibizumab in people with Epiretinal Membrane, run by Queen's University at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether intraocular injection of ranibizumab decreases the retinal thickness in patients with epiretinal membranes and reduces associated symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- intravitreal ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Jan 2012
- 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
- symptomatic idiopathic epiretinal membrane
Who cannot join
- vision worse than 6/18 and fit for surgery
- prior vitreoretinal surgery or injection
- diabetes
- any past or current form of retinal vein occlusion or neovascularization
- age-related macular degeneration
- other condition causing significant limitation of visual potential
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen's University, Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
About this study
Official title: A Prospective Pilot Study of Lucentis for Epiretinal Membranes: the LERM Study
The purpose of this study is to determine whether intraocular injection of ranibizumab decreases the retinal thickness in patients with epiretinal membranes and reduces associated symptoms.
- Conditions
- Epiretinal Membrane
- Being tested
- intravitreal ranibizumab
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal ranibizumabDrug
Also called Lucentis
monthly injections x3 +/- 2nd series of 3
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | ('intravitreal ranibizumab' ) Receives: Drug: intravitreal ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of improvement measured by optical coherence tomography
Measured: 3 and 6 months
Secondary outcomes (5)
Distance visual acuity (ETDRS)
Measured: 3 and 6 months
Near visual acuity (Snellen)
Measured: 3 and 6 months
Subjective change in symptoms
Measured: 3 and 6 months
Amsler grid improvement
Measured: 3 and 6 months
Quality of life improvement
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 posted10 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Gale, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238393
- Sponsor's protocol ID
- OPTH-092-10
- Acronym
- LERM
- Status last verified
- Jan 2016
- First submitted
- 9 Nov 2010
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study of Lucentis for Epiretinal Membranes: the LERM Study
- ClinicalTrials.gov ID
- NCT01238393
- Acronym / sponsor ID
- LERM / OPTH-092-10
- Conditions
- Epiretinal Membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Nov 2010 (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.
The purpose of this study is to determine whether intraocular injection of ranibizumab decreases the retinal thickness in patients with epiretinal membranes and reduces associated symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: intravitreal ranibizumab('intravitreal ranibizumab' ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- symptomatic idiopathic epiretinal membrane
Key exclusion criteria (6 listed)
- vision worse than 6/18 and fit for surgery
- prior vitreoretinal surgery or injection
- diabetes
- any past or current form of retinal vein occlusion or neovascularization
- age-related macular degeneration
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 |
|---|---|---|
| intravitreal ranibizumabAlso: Lucentismonthly injections x3 +/- 2nd series of 3 | Drug | Ranibizumab |
Primary outcome
Evidence of improvement measured by optical coherence tomography
Time frame: 3 and 6 months
5 secondary outcomes
Distance visual acuity (ETDRS)
Time frame: 3 and 6 months
Near visual acuity (Snellen)
Time frame: 3 and 6 months
Subjective change in symptoms
Time frame: 3 and 6 months
Amsler grid improvement
Time frame: 3 and 6 months
Quality of life improvement
Time frame: 6 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 13 Jan 2016.
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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.
Jeffrey Gale, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravitreal ranibizumab in people with Epiretinal Membrane, run by Queen's University at 1 site in Canada.
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 1 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 13 Jan 2016. 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 Canada. 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?
Evidence of improvement measured by optical coherence tomography (time frame: 3 and 6 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 13 Jan 2016.