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Nepafenac Once Daily for Macular Edema - Study 1

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01853072
First received: May 10, 2013
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Non-Proliferative Diabetic Retinopathy
Cataract
Drug: Nepafenac Ophthalmic Suspension, 0.3%
Other: Nepafenac vehicle
Drug: Prednisolone acetate ophthalmic suspension
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 590
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Nepafenac Ophthalmic Suspension, 0.3% 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™
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.
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™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853072

Contacts
Contact: Alcon Call Center 1-888-451-3937 alcon.medinfo@alcon.com

Locations
United States, Texas
Contact Alcon Call Center at 1-888-451-3937 for Trial Locations Recruiting
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Abhijit Narvekar, MS, MBBS Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01853072     History of Changes
Other Study ID Numbers: C-12-067
Study First Received: May 10, 2013
Last Updated: October 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Diabetes Type I
Diabetes Type II
non-proliferative diabetic retinopathy
macular edema
Cataract

Additional relevant MeSH terms:
Cataract
Diabetic Retinopathy
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Lens Diseases
Vascular Diseases
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Nepafenac
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on November 27, 2014