Macular EdemaPhase 2NCT00782717

A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients

A Phase 2 study testing Nepafenac ophthalmic suspension, 0.1% (NEVANAC) and Prednisolone acetate ophthalmic suspension (OMNIPRED) in people with Macular Edema, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Macular Edema
What is being tested?: Nepafenac ophthalmic suspension, 0.1% (NEVANAC) and Prednisolone acetate ophthalmic suspension (OMNIPRED)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 263 participants
Where: No sites listed yet
Study dates: Nov 2008to Jul 2010
Phase: Phase 2
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

Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Central subfiled macular thickness greater than or equal to 250 microns
CME in either eye.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients

The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.

Conditions: Macular Edema
Being tested: Nepafenac ophthalmic suspension, 0.1% (NEVANAC), Nepafenac ophthalmic suspension vehicle, Prednisolone acetate ophthalmic suspension (OMNIPRED)
Keywords: diabetic retinopathy, cystoid macular edema;
Medical subject headings: Macular Edema, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nepafenac ophthalmic suspension, 0.1% (NEVANAC)Drug
Also called NEVANAC
1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.
Nepafenac ophthalmic suspension vehicleOther
1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
Prednisolone acetate ophthalmic suspension (OMNIPRED)Drug
Also called OMNIPRED
One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.

Study groups in NCT00782717
Study group	Role	What they receive
NEVANAC	Experimental	One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. Receives: Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC); Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)
Nepafenac Vehicle	Placebo comparator	One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter. Receives: Other: Nepafenac ophthalmic suspension vehicle; Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).
Measured: 3 Months

Secondary outcomes (1)

Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.
Measured: From Day 7 to Day 90 (or Early Exit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Jul 2010

First posted31 Oct 2008 (estimated)
Study startNov 2008
Primary completionJul 2010
Study completionJul 2010

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 (2)Papers the sponsor has linked to this study.
Other trials for Macular EdemaStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00782717
Sponsor's protocol ID: C-07-43
Status last verified: Oct 2012
First submitted: 29 Oct 2008
Last updated: 26 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Singh R, Alpern L, Jaffe GJ, Lehmann RP, Lim J, Reiser HJ, Sall K, Walters T, Sager D. Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy. Clin Ophthalmol. 2012;6:1259-69. doi: 10.2147/OPTH.S31902. Epub 2012 Aug 3.
PubMed 22927737
Pollack A, Staurenghi G, Sager D, Mukesh B, Reiser H, Singh RP. Prospective randomised clinical trial to evaluate the safety and efficacy of nepafenac 0.1% treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy. Br J Ophthalmol. 2017 Apr;101(4):423-427. doi: 10.1136/bjophthalmol-2016-308617. Epub 2016 Jul 7.
PubMed 27388251

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)

All Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
ClinicalTrials.gov ID: NCT00782717
Acronym / sponsor ID: C-07-43
Conditions: Macular Edema
Keywords: diabetic retinopathy, cystoid macular edema;
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 263 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 31 Oct 2008 (estimated)
Results: Posted 21 Sep 2011

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 nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
NEVANAC	Experimental	Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC), Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
Nepafenac Vehicle	Placebo comparator	Other: Nepafenac ophthalmic suspension vehicle, Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED)One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (3 listed)

Central subfiled macular thickness greater than or equal to 250 microns
CME in either eye.
Other protocol-defined exclusion criteria may apply.

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 ophthalmic suspension, 0.1% (NEVANAC)Also: NEVANAC1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.	Drug	NEVANAC
Nepafenac ophthalmic suspension vehicle1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery	Other	Nepafenac Vehicle
Prednisolone acetate ophthalmic suspension (OMNIPRED)Also: OMNIPREDOne drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.	Drug	NEVANAC, Nepafenac Vehicle

Primary outcome

Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
Time frame: 3 Months
Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).

1 secondary outcome

Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).
Time frame: From Day 7 to Day 90 (or Early Exit)

Results and safety

Results posted to the registry on 21 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NEVANAC	133	118
Nepafenac Vehicle	130	102

Primary outcome: Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery

Time frame: 3 Months. Number. Unit: Percentage of patients

Measure	NEVANAC n = 125	Nepafenac Vehicle n = 126
Value	3	17

Population analysed: All patients who were exposed to the study drug, completed the implant surgery, and had at least one on-therapy post-surgical visit at which optical coherence tomography (OCT) was performed (ITT).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study: 04 NOV 2008 to 15 JUL 2010.. Other adverse events reported at 2.4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NEVANAC	4 of 126 (3.2%)	9 of 126 (7.1%)	Not reported
Nepafenac Vehicle	9 of 127 (7.1%)	19 of 127 (15%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22927737Singh R, Alpern L, Jaffe GJ, Lehmann RP, Lim J, Reiser HJ, Sall K, Walters T, Sager D. Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy. Clin Ophthalmol. 2012;6:1259-69. doi: 10.2147/OPTH.S31902. Epub 2012 Aug 3.
Derived from this study: PubMed 27388251Pollack A, Staurenghi G, Sager D, Mukesh B, Reiser H, Singh RP. Prospective randomised clinical trial to evaluate the safety and efficacy of nepafenac 0.1% treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy. Br J Ophthalmol. 2017 Apr;101(4):423-427. doi: 10.1136/bjophthalmol-2016-308617. Epub 2016 Jul 7.

Related trials for Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nepafenac ophthalmic suspension, 0.1% (NEVANAC) and Prednisolone acetate ophthalmic suspension (OMNIPRED) in people with Macular Edema, run by Alcon Research.

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 2 inclusion and 3 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 26 Oct 2012. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2011). 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?

Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery (time frame: 3 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 NCT00782717, which also lists 2 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 26 Oct 2012.