Nepafenac Once Daily for Macular Edema - Study 1

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01853072
First received: May 10, 2013
Last updated: July 22, 2014
Last verified: July 2014

May 10, 2013
July 22, 2014
June 2013
March 2015   (final data collection date for primary outcome measure)
Proportion of subjects with BCVA improvement of ≥ 15 letters from preoperative baseline to Day 14 and maintained through Day 90 [ Time Frame: Baseline, up to Day 90 ] [ Designated as safety issue: No ]
As measured with Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity charts
Same as current
Complete list of historical versions of study NCT01853072 on ClinicalTrials.gov Archive Site
  • Proportion of subjects who develop macular edema (defined as ≥ 30% increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery [ Time Frame: Baseline, up to Day 90 ] [ Designated as safety issue: No ]
    As measured with Spectral Domain Ocular Coherence Tomography (SD-OCT)
  • Proportion of subjects with BCVA improvement of ≥ 15 letters from preoperative baseline to Day 90 [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    As measured with Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity charts
  • Proportion of subjects with BCVA improvement of ≥ 15 letters from preoperative baseline to Day 60 [ Time Frame: Baseline, Day 60 ] [ Designated as safety issue: No ]
    As measured with Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity charts
Same as current
Not Provided
Not Provided
 
Nepafenac Once Daily for Macular Edema - Study 1
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery

The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic subjects following cataract surgery.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Non-Proliferative Diabetic Retinopathy
  • Cataract
  • Drug: Nepafenac Ophthalmic Suspension, 0.3%
  • Other: Nepafenac vehicle
    Inactive ingredients used as placebo comparator
  • Drug: Prednisolone acetate ophthalmic suspension
    1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks
    Other Name: Omnipred™
  • Experimental: Nepafenac
    Nepafenac Ophthalmic Suspension, 0.3%, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
    Interventions:
    • Drug: Nepafenac Ophthalmic Suspension, 0.3%
    • Drug: Prednisolone acetate ophthalmic suspension
  • Placebo Comparator: Vehicle
    Nepafenac vehicle, 1 drop instilled in the operative eye 1 day prior to surgery, continuing on the day of surgery, and for 90 days following surgery. An additional 1 drop will be administered 30 to 120 minutes prior to surgery.
    Interventions:
    • Other: Nepafenac vehicle
    • Drug: Prednisolone acetate ophthalmic suspension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
590
March 2015
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens;
  • History of Type 1 or 2 diabetes and non-proliferative diabetic retinopathy (NPDR) (mild, moderate, or severe) in the study eye;
  • Best corrected visual acuity (BCVA) of 73 letters or worse in the study eye with expectation of improvement after surgery;
  • Understand and sign an informed consent document;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pre-existing macular edema in the study eye;
  • History in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures;
  • Planned cataract surgery in the fellow eye after randomization and prior to the Day 90 postoperative study visit or through study exit;
  • Planned multiple procedures for the study eye during the cataract/intraocular lens implantation surgery;
  • Use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids, as specified in protocol.
  • Participation in any other clinical study within 30 days of the screening visit;
  • Females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study;
  • Other protocol-defined exclusion criteria may apply.
Both
18 Years and older
No
Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com
United States
 
NCT01853072
C-12-067
No
Alcon Research
Alcon Research
Not Provided
Study Director: Abhijit Narvekar, MS, MBBS Alcon Research
Alcon Research
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP