E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Demonstrate superiority of NEVANAC(nepafenac ophthalmic suspension) 0.1% relative to nepafenac vehicle based on the percentage of diabetic retinopathy patients who develop macular edema (defined as ≥30% increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Patients must be 18 years of age and older, of any race and either sex, who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens into the lens capsule 2) History of Type 1 or Type 2 diabetes 3) NPDR (mild, moderate or severe) in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale 4) Patients must be able to understand and sign an informed consent that has been approved by an Institutional Review Board (IRB) 5) Central subfield macular thickness ≤ 320 μm in the study eye prior to cataract surgery as determined by SD-OCT and confirmed by the reading center 6) Absence of CME or cystoid abnormalities in the study eye as detected by SD-OCT and confirmed by the reading center 7) Absence of clinically significant macular edema (CSME) in the study eye as detected by clinical exam |
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E.4 | Principal exclusion criteria |
1) Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by reading center or investigator Current or previous ocular disease in the study eye that in the opinion of the investigator may confound assessment of the macula, the retina, or central vision, other that diabetic retinopathy 3) Focal photocoagulation for the treatment of diabetic macular edema in the study eye within 6 months of the pre-operative baseline visit (Note: peripheral retina treatment for retinal tear or lattice degeneration is permitted) 4) Prior panretinal photocoagulation in the study eye 5) Planned multiple procedures for study eye during the cataract/IOL implantation surgery (e.g., trabeculectomy, corneal transplant) 6) Patients who have received corneal transplants in the study eye 7) Patients whose baseline cumulative corneal fluorescein staining score (i.e., sum of scores for all 5 corneal regions) for the study eye is graded as ≥5, or whose baseline corneal fluorescein staining score in any single region for the study eye is graded as ≥3 8) History of iris atrophy or chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, uveitis, iridocyclitis) in the study eye 9) Patients with a visually nonfunctional fellow eye, defined as a best-corrected visual acuity of ≤35 ETDRS letters or worse (Snellen equivalent 20/200), except when the acuity decrease is caused by a cataract. 10) Patients who are immunocompromised (e.g., patients receiving chemotherapy irradiation therapy, patients with AIDS, leukemia, or cachexia) or patients receiving dialysis 11) Patients, who in the opinion of the investigator, might be at increased risk of complications from topical NSAIDs including those with current or history of keratoconjunctivitis sicca (dry eye syndrome), neurotrophic keratopathy, lid or orbit abnormalities and collagen vascular disease |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients who develop macular edema (defined as ≥30% increase from pre-operative baseline in central subfield macular thickness) within 90 days following cataract surgery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |