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OpenTrials
Completed

NCT Number: NCT00782717

A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After 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.

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Key information

Conditions

Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: NEVANAC

Nepafenac ophthalmic suspension vehicle

Other

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

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

Other names: OMNIPRED

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

    BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 31, 2008
Registry last updated
Oct 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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