NCT00939276

Brief Summary

The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
175

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

July 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

July 10, 2009

Last Update Submit

October 18, 2012

Conditions

Diabetic Retinopathy

Keywords

cataract surgerymacular edemaprevention

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients who develop macular edema within 90 days following cataract surgery

    Time to event

Secondary Outcomes (1)

  • Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90

    Baseline, Day 90

Study Arms (2)

NEVANAC

EXPERIMENTAL

One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery

Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)

Nepafenac Vehicle

PLACEBO COMPARATOR

One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery

Drug: Nepafenac ophthalmic suspension vehicle

Interventions

Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)DRUG

One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) 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 vehicleDRUG

One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery

Nepafenac Vehicle

Eligibility Criteria

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

You may qualify if:

  • Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens (IOL) into the lens capsule.
  • History of Type 1 or Type 2 diabetes.
  • History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe, in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale.
  • Able to understand and sign an informed consent approved by an IRB/IEC.
  • Central subfield macular thickness less than or equal to 320 μm in the study eye prior to cataract surgery.
  • Absence of clinically significant macular edema in the study eye as detected by clinical exam.

You may not qualify if:

  • Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by the reading center or Investigator.
  • Current or previous ocular disease other than diabetic retinopathy in the study eye that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision.
  • Planned multiple procedures for the study eye during the cataract/IOL implantation surgery (eg, trabeculoplasty, corneal transplant).
  • Corneal transplant in study eye.
  • Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to 3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Location

Related Publications (1)

  • 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

Diabetic RetinopathyMacular Edema

Interventions

nepafenac

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesMacular DegenerationRetinal Degeneration

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 14, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2011

Study Completion

August 1, 2011

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations

US(1)