Epiretinal MembranePhase 4NCT00818844
Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery
A Phase 4 study testing Nepafenac 0.1% and BSS in people with Epiretinal Membrane, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to compare the macular volume of patients treated with a 3-month course of topical Nepafenac (0.1% solution) to patients treated with a placebo course following epiretinal membrane surgery. 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?
- Nepafenac 0.1% and BSS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jun 2010
- 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
- 18 year of age or older, of any race and either sex.
- Able to understand and sign an informed consent that has been approved by an Institutional Review Board.
- Must agree to comply with study visit schedule and other study requirements.
- Must have vision loss associated with idiopathic epiretinal membrane and secondary retinal edema.
- Must have pre-operative central foveal thickness greater than 300 microns.
- Prior cataract surgery must be at least 6 months postoperative.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Vision loss associated with maculopathies other than idiopathic epiretinal membrane and secondary retinal edema (e.g. branch retinal vein occlusion, central retinal vein occlusion, wet macular degeneration, diabetic retinopathy, posterior uveitis).
- Dry macular degeneration (drusen) with central geographic atrophy.
- Concomitant cataract surgery performed at the time of study vitrectomy.
- Prior vitrectomy surgery in the study eye(s).
- Prior macula laser treatment in the study eye(s).
- Prior periocular steroid injections in the study eye(s) within preceding 6 months.
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- Prior cataract surgery in the study eye(s) within the last 6 months.
- Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- Use of topical ocular medications during the study period.
- Antibiotics (systemic or topical) outside of study protocol may not be used within 7 days of preoperative/baseline visit or anytime after this visit for the duration of the study.
- Women of childbearing potential not using reliable means of birth control.
- Women who are pregnant or lactating.
- Enrollment of more than one person per household at the same time.
- Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
- Participation in any investigational drug or device study within 30 days of entering this study. Note: Patients may have both eyes enrolled in this study provided that 2nd eye enrollment takes place 30 days after completion of the first eye. Second eye will receive the same study treatment as first eye.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the macular volume of patients treated with a 3-month course of topical Nepafenac (0.1% solution) to patients treated with a placebo course following epiretinal membrane surgery.
- Conditions
- Epiretinal Membrane
- Being tested
- Nepafenac 0.1%, BSS
- Keywords
- Nepafenac, vitrectomy surgery, Epiretinal membrane surgery
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepafenac 0.1%Drug
NSAID
BSSOther
BSS
| Study group | Role | What they receive |
|---|---|---|
| Nepafenac | Experimental | Nepafenac 0.1% dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery Receives: Drug: Nepafenac 0.1% |
| BSS | Placebo comparator | BSS dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery Receives: Other: BSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular thickness
Macular thickness as measured by SD-OCT
Measured: 12 weeks post operative
Secondary outcomes (1)
Visual Acuity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818844
- Sponsor's protocol ID
- SMA-08-10
- Status last verified
- Feb 2012
- First submitted
- 6 Jan 2009
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Schoenberger SD, Miller DM, Petersen MR, Foster RE, Riemann CD, Sisk RA. Nepafenac for epiretinal membrane surgery. Ophthalmology. 2011 Jul;118(7):1482.e1-3. doi: 10.1016/j.ophtha.2011.01.034. No abstract available.
PubMed 21724047
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nepafenac in Reducing Macular Volume After Epiretinal Membrane Surgery
- ClinicalTrials.gov ID
- NCT00818844
- Acronym / sponsor ID
- SMA-08-10
- Conditions
- Epiretinal Membrane
- Keywords
- Nepafenac, vitrectomy surgery, Epiretinal membrane surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Jan 2009 (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 compare the macular volume of patients treated with a 3-month course of topical Nepafenac (0.1% solution) to patients treated with a placebo course following epiretinal membrane surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nepafenac | Experimental | Drug: Nepafenac 0.1%Nepafenac 0.1% dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery |
| BSS | Placebo comparator | Other: BSSBSS dosed topically TID for 3 months after Epiretinal Membrane (ERM) Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 year of age or older, of any race and either sex.
- Able to understand and sign an informed consent that has been approved by an Institutional Review Board.
- Must agree to comply with study visit schedule and other study requirements.
- Must have vision loss associated with idiopathic epiretinal membrane and secondary retinal edema.
- Must have pre-operative central foveal thickness greater than 300 microns.
Key exclusion criteria (16 listed)
- Vision loss associated with maculopathies other than idiopathic epiretinal membrane and secondary retinal edema (e.g. branch retinal vein occlusion, central retinal vein occlusion, wet macular degeneration, diabetic retinopathy, posterior uveitis).
- Dry macular degeneration (drusen) with central geographic atrophy.
- Concomitant cataract surgery performed at the time of study vitrectomy.
- Prior vitrectomy surgery in the study eye(s).
- Prior macula laser treatment in the study eye(s).
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 |
|---|---|---|
| Nepafenac 0.1%NSAID | Drug | Nepafenac |
| BSSBSS | Other | BSS |
Primary outcome
Macular thickness
Time frame: 12 weeks post operative
Macular thickness as measured by SD-OCT
1 secondary outcome
Visual Acuity
Time frame: 3 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 14 Aug 2015.
- Derived from this study: PubMed 21724047Schoenberger SD, Miller DM, Petersen MR, Foster RE, Riemann CD, Sisk RA. Nepafenac for epiretinal membrane surgery. Ophthalmology. 2011 Jul;118(7):1482.e1-3. doi: 10.1016/j.ophtha.2011.01.034. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nepafenac 0.1% and BSS in people with Epiretinal Membrane, run by Alcon Research at 1 site in United States.
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 16 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 14 Aug 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 United States. 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 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?
Macular thickness (time frame: 12 weeks post operative). 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 NCT00818844, which also lists 1 linked publication.
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 14 Aug 2015.