Cystoid Macular EdemaNCT03025945
Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
A study testing Nepafenac 0.3% and Saline Solution in people with Cystoid Macular Edema, run by Intuor Technologies, Inc..
Trial summary
Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoid Macular Edema
- What is being tested?
- Nepafenac 0.3% and Saline Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 662 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.
Who cannot join
- previous uveitis (<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs
About this study
Official title: Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.
- Conditions
- Cystoid Macular Edema
- Being tested
- Nepafenac 0.3%, Saline Solution
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nepafenac 0.3%Drug
Saline SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| nepafenac 0.3% | Experimental | nepafenac 0.3% ophthalmic solution dosed once daily Receives: Drug: Nepafenac 0.3% |
| Saline Solution | Placebo comparator | sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Clinical Findings of Cystoid Macular Edema
post-operative macular volume (mm)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startOct 2013
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystoid Macular EdemaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuor Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean McCafferty, MD, Principal investigator, Arizona Eye Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025945
- Sponsor's protocol ID
- CME and nepafenac 0.3%
- Status last verified
- Dec 2018
- First submitted
- 14 Jan 2017
- Last updated
- 14 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McCafferty S, Harris A, Kew C, Kassm T, Lane L, Levine J, Raven M. Pseudophakic cystoid macular edema prevention and risk factors; prospective study with adjunctive once daily topical nepafenac 0.3% versus placebo. BMC Ophthalmol. 2017 Feb 20;17(1):16. doi: 10.1186/s12886-017-0405-7.
PubMed 28219426
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudophakic Cystoid Macular Edema Prevention and Risk Factors; Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo
- ClinicalTrials.gov ID
- NCT03025945
- Acronym / sponsor ID
- CME and nepafenac 0.3%
- Conditions
- Cystoid Macular Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- Intuor Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Posted 14 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nepafenac 0.3% | Experimental | Drug: Nepafenac 0.3%nepafenac 0.3% ophthalmic solution dosed once daily |
| Saline Solution | Placebo comparator | Drug: Saline Solutionsterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.
Key exclusion criteria (1 listed)
- previous uveitis (<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs
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 0.3% | Drug | nepafenac 0.3% |
| Saline Solution | Drug | Saline Solution |
Primary outcome
Post-operative Clinical Findings of Cystoid Macular Edema
Time frame: 6 weeks
post-operative macular volume (mm)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28219426McCafferty S, Harris A, Kew C, Kassm T, Lane L, Levine J, Raven M. Pseudophakic cystoid macular edema prevention and risk factors; prospective study with adjunctive once daily topical nepafenac 0.3% versus placebo. BMC Ophthalmol. 2017 Feb 20;17(1):16. doi: 10.1186/s12886-017-0405-7.
- Individual participant dataSharing planned: No
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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.
Sean McCafferty, MD principal investigator
Arizona Eye Consultants
Questions about this trial
What is this clinical trial studying?
A study testing Nepafenac 0.3% and Saline Solution in people with Cystoid Macular Edema, run by Intuor Technologies, Inc..
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 1 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Clinical Findings of Cystoid Macular Edema (time frame: 6 weeks). 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 NCT03025945, 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 Dec 2018.