A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle After Cataract Surgery in Diabetic Retinopathy Patients
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| ClinicalTrials.gov Identifier: NCT00782717 |
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Recruitment Status :
Completed
First Posted : October 31, 2008
Results First Posted : September 21, 2011
Last Update Posted : October 26, 2012
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Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Macular Edema | Drug: Nepafenac ophthalmic suspension, 0.1% (NEVANAC) Other: Nepafenac ophthalmic suspension vehicle Drug: Prednisolone acetate ophthalmic suspension (OMNIPRED) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 263 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients |
| Study Start Date : | November 2008 |
| Actual Primary Completion Date : | July 2010 |
| Actual Study Completion Date : | July 2010 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Nepafenac
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: 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.
Other Name: NEVANAC Drug: 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.
Other Name: OMNIPRED |
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Placebo Comparator: 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.
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Other: 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 Drug: 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.
Other Name: OMNIPRED |
Primary Outcome Measures :
- Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery [ Time Frame: 3 Months ]Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).
Secondary Outcome Measures :
- Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA). [ Time Frame: From Day 7 to Day 90 (or Early Exit) ]BCVA was measured using the procedure developed for the Early Treatment Diabetic Retinopathy Study.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Central subfiled macular thickness greater than or equal to 250 microns
- CME in either eye.
- Other protocol-defined exclusion criteria may apply.
No Contacts or Locations Provided
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT00782717 |
| Other Study ID Numbers: |
C-07-43 |
| First Posted: | October 31, 2008 Key Record Dates |
| Results First Posted: | September 21, 2011 |
| Last Update Posted: | October 26, 2012 |
| Last Verified: | October 2012 |
Keywords provided by Alcon Research:
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diabetic retinopathy cystoid macular edema; |
Additional relevant MeSH terms:
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Cataract Macular Edema Retinal Diseases Diabetic Retinopathy Lens Diseases Eye Diseases Macular Degeneration Retinal Degeneration Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Prednisolone |
Methylprednisolone Acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone acetate Nepafenac Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics |