Macular Edema Incidence/Severity Reduction With Nevanac

Alcon

Status and phase: Terminated; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Drug: Nepafenac ophthalmic suspension vehicle; Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00939276

EudraCT Number: 2009-010536-17

C-09-003

Details and patient eligibility

About

The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens (IOL) into the lens capsule.
• History of Type 1 or Type 2 diabetes.
• History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe, in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale.
• Able to understand and sign an informed consent approved by an IRB/IEC.
• Central subfield macular thickness less than or equal to 320 μm in the study eye prior to cataract surgery.
• Absence of clinically significant macular edema in the study eye as detected by clinical exam.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by the reading center or Investigator.
• Current or previous ocular disease other than diabetic retinopathy in the study eye that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision.
• Planned multiple procedures for the study eye during the cataract/IOL implantation surgery (eg, trabeculoplasty, corneal transplant).
• Corneal transplant in study eye.
• Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to 3.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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175 participants in 2 patient groups, including a placebo group

NEVANAC

Experimental group

Description:

One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery

Treatment:

Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®)

Nepafenac Vehicle

Placebo Comparator group

Description:

One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery

Treatment:

Drug: Nepafenac ophthalmic suspension vehicle