NCT00782717

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 21, 2011

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

October 29, 2008

Results QC Date

August 17, 2011

Last Update Submit

October 22, 2012

Conditions

Macular Edema

Keywords

diabetic retinopathycystoid macular edema;

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 Months

Secondary Outcomes (1)

  • Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).

    From Day 7 to Day 90 (or Early Exit)

Study Arms (2)

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.

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.

Other: Nepafenac ophthalmic suspension vehicleDrug: Prednisolone acetate ophthalmic suspension (OMNIPRED)

Interventions

Nepafenac ophthalmic suspension, 0.1% (NEVANAC)DRUG

1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.

Also known as: NEVANAC
NEVANAC
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

Nepafenac Vehicle
Prednisolone acetate ophthalmic suspension (OMNIPRED)DRUG

One drop in the study eye 4 times daily (morning, late morning, late afternoon, and bedtime)for two weeks postsurgery.

Also known as: OMNIPRED
NEVANACNepafenac Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.

You may not qualify if:

  • Central subfiled macular thickness greater than or equal to 250 microns
  • CME in either eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 22927737RESULT

  • 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.

    PMID: 27388251DERIVED

MeSH Terms

Conditions

Macular EdemaDiabetic Retinopathy

Interventions

nepafenacMethylprednisolone

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Director of Alcon Clinical
Organization
Alcon Research, Ltd.
medinfo@alconlabs.com
888.451.3937 and 817.568.6725

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2008

First Posted

October 31, 2008

Study Start

November 1, 2008

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 26, 2012

Results First Posted

September 21, 2011

Record last verified: 2012-10