MedDataX Logo

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

NCT ID: NCT00782717

Last Updated: 2012-10-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Edema

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

diabetic retinopathy cystoid macular edema;

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NEVANAC

One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.

Group Type EXPERIMENTAL

Nepafenac ophthalmic suspension, 0.1% (NEVANAC)

Intervention Type DRUG

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)

Intervention Type DRUG

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

Nepafenac Vehicle

One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.

Group Type PLACEBO_COMPARATOR

Nepafenac ophthalmic suspension vehicle

Intervention Type 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)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nepafenac ophthalmic suspension, 0.1% (NEVANAC)

1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery.

Intervention Type DRUG

Nepafenac ophthalmic suspension vehicle

1 drop TID beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery

Intervention Type OTHER

Prednisolone acetate ophthalmic suspension (OMNIPRED)

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NEVANAC OMNIPRED

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.

Exclusion Criteria

* Central subfiled macular thickness greater than or equal to 250 microns
* CME in either eye.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Singh R, Alpern L, Jaffe GJ, Lehmann RP, Lim J, Reiser HJ, Sall K, Walters T, Sager D. Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy. Clin Ophthalmol. 2012;6:1259-69. doi: 10.2147/OPTH.S31902. Epub 2012 Aug 3.

Reference Type RESULT
PMID: 22927737 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27388251 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-07-43

Identifier Type: -

Identifier Source: org_study_id