E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Age related Macular Degeneration (AMD) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064930 |
E.1.2 | Term | Age-related macular degeneration |
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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 |
Determine the pharmacodynamics of ocular blood flow (time course and maximum effect) measurements with multiple drop unoprostone (Isopropyl) vs Placebo |
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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. Age ≥ 50 years at screening 2. Ametropy ≤ 3 diopters 3. Clear ocular media 4. Visual acuity in the study eye > 20/40 5. Subject has dry AMD in the study eye and a documented history of CNV in the contralateral eye 6. If subject is taking a nutritional supplement containing zinc, lutein, zeaxanthin, and/or omega 3, usage schedule and dose must have been stable for at least 30 days prior to the Screening Visit and expected to continue unchanged during the course of the study 7. Subject has read, understood, and signed the Informed Consent Form (ICF) 8. Subject is able to communicate well with the Investigator and is able to comply with the requirements of the entire study |
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E.4 | Principal exclusion criteria |
1. Presence of any ocular condition in the study eye (other than AMD) that may progress during the course of the study and could affect central vision or other ocular conditions that may be a confounding factor in this study 2. Presence of retinal vein occlusion, retinal artery occlusion or ischemic optic neuropathy in the study eye 3. Presence of glaucoma in the study eye 4. Ocular infection or inflammation in the study eye (current or prior) within the previous 3 months 5. Any chronic retinopathy or retinal degenerative disease other than AMD, such as retinitis pigmentosa or diabetic retinopathy 6. History of intraocular surgery or clinically-significant ocular trauma in the study eye within 6 months of enrollment 7. Blood donation during the previous 3 weeks 8. Current smoker or history of smoking within 5 years of enrollment 9. Concomitant treatment with latanoprost, bimatoprost, brimonidine, timolol, travoprost,betaxolol, prostaglandins; calcium channel blockers, nitrates, carbonic anhydrase inhibitors, any other medication used for the treatment of glaucoma, and/or treatment with any systemic or ocular medication that is known to be toxic to the lens, retina, cornea, or optic nerve within 21 days of Day 0. 10. According to Investigator’s clinical judgment, patient has clinically significant, unexplained cardiovascular, liver or lung disease, neurologic or psychiatric disorders (excluding depression), or any other systemic disease. If explained, the subject may be enrolled, if in the Investigator’s opinion, the condition would not interfere with safety or efficacy assessments, or result in an increased risk of participation to the subject. 11. Subject has a history of alcohol or drug abuse within 90 days prior to Screening Visit. 12. Subject has participated in another trial with an investigational drug, device, or procedure within the 30 days preceding the Screening Visit. 13. Female Subject of childbearing potential is unable or unwilling to use a protocolspecified method of birth control. 14. Female subject of childbearing potential has a positive screening pregnancy test, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study. 15. Subject demonstrates a potential for non-compliance with the study protocol (i.e., dosing schedule, visit schedule, or study procedures). 16. Prior exposure to Rescula (unoprostone isopropyl ophthalmic solution) and/or a known hypersensitivity to any of the components of investigational product (e.g. benzalkonium chloride). |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint will be choroidal blood flow as assessed by Laser Doppler Flowmetry. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.6 | Cross over | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 15 |