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Nepafenac Once Daily for Macular Edema - Study 1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01853072
First received: May 10, 2013
Last updated: June 23, 2016
Last verified: June 2016
  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
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:
  • Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90 [ Time Frame: Baseline to Day 14, and maintained through Day 90 ] [ Designated as safety issue: No ]
    BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.

  • Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0) [ Time Frame: Day 0 to Day 90 ] [ Designated as safety issue: No ]
    Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.


Secondary Outcome Measures:
  • Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90 [ Time Frame: Baseline to Day 90 ] [ Designated as safety issue: No ]
  • Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60 [ Time Frame: Baseline to Day 60 ] [ Designated as safety issue: No ]
  • Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit] [ Time Frame: Day 7 up to any visit through Day 90 ] [ Designated as safety issue: No ]
  • Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit [ Time Frame: Day 7 up to any visit through Day 90 ] [ Designated as safety issue: No ]

Enrollment: 881
Study Start Date: June 2013
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nepafenac
With prednisolone acetate standard of care, 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%
Test intervention
Other Name: Nepafenac
Drug: Prednisolone acetate
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 Names:
  • Omnipred™
  • Prednisolone acetate ophthalmic suspension
Placebo Comparator: Vehicle
With prednisolone acetate standard of care, 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
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 Names:
  • Omnipred™
  • Prednisolone acetate ophthalmic suspension

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Clinical Project Lead GCRA, Pharma Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01853072     History of Changes
Other Study ID Numbers: C-12-067 
Study First Received: May 10, 2013
Results First Received: May 13, 2016
Last Updated: June 23, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Colombia: Ethics Committee
Dominican Republic: Consejo Nacional de Bioetica en Salud
Mexico: Institutional Review Board
Panama: Commemorative Institute GORGAS of Studies of Health

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

Additional relevant MeSH terms:
Macular Edema
Cataract
Retinal Diseases
Diabetic Retinopathy
Macular Degeneration
Retinal Degeneration
Eye Diseases
Lens Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nepafenac
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 07, 2016