E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
macular edema following cataract surgery |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054467 |
E.1.2 | Term | Macular edema |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051240 |
E.1.2 | Term | Cystoid macular edema |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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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 | |
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) 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 5) Absence of CME or cystoid abnormalities in the study eye as detected by SD-OCT and confirmed by the reading center 6) 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 |
Exclusions related to patient history or current ocular conditions: 1) Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by reading center or investigator 2) 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) Patients with history of iris atrophy or current or history of chronic or recurrent ocular infections or inflammation in the study eye 9) Patients with a visually non-functional fellow eye based upon the assessment by the investigator. 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 or steroids including those with current or history of keratoconjunctivitis sicca (dry eye syndrome), neurotrophic keratopathy, corneal or scleral thinning and collagen vascular disease, contact lens users, and those with known bleeding tendencies 12) Patients with current or history of asthma, urticaria, or acute rhinitis in whom attacks are precipitated by acetylsalicylic acid or other NSAIDs 13) Use of medications known to affect the macula, including hydroxychloroquinine (Plaquenil) and phenothiozines (e.g., thioridazine [Mellaril], chloropromazine [Thorazine]) or supplemental niacin ≥3 grams/day 14) Use of daily doses of systemic steroids and NSAIDS within 7 days prior to surgery (through study exit). Daily doses of aspirin, up to 325 mg, will be permitted. 15) Use of daily doses of topical ocular steroids and NSAIDs in the nonstudy eye through study exit (Note: All topical ocular steroids and NSAIDs must be discontinued 1 day prior to surgery) 16) Use of topical ocular NSAIDS and steroids, in the study eye, within 7 days prior to surgery 17) Treatment with intraocular or periocular steroids in the study eye within 4 months prior to surgery 18) Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication including Tobradex® 19) Use of a topical ophthalmic prostaglandin (e.g., TRAVATAN, XALATAN) within 4 days of surgery through study exit 20) The Alcon Medical Monitor may declare any patient ineligible for a valid medical reason. 21) Participation in any other clinical study within 30 days of the Baseline examination 22) Each patient will have only one eye enrolled in the study 23) Females of childbearing potential (those who are not surgically sterilized or post-menopausal) may not participate in the study if any of the following conditions exist: they are breast-feeding; they have a positive urine pregnancy test at screening; they are not willing to undergo a urine pregnancy test upon entering or exiting the study; they intend to become pregnant during the study; or, they do not agree to use adequate birth control methods for the duration of the study (adequate birth control methods are: hormonal - oral, implantable, transdermal, or injectable contraceptives; mechanical - spermicide in conjunction with a barrier such as condom or diaphragm; IUD; or, surgical sterilization of partner) |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 5 |
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
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Enrollment of approximately 260 patients (130 per treatment group) to obtain 222 patients who are evaluable per protocol (111 per treatment group) |
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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 | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |