Age related Macular Degeneration (AMD) MedDRA version: 12.1 Level: LLT Classification code 10064930 Term: Age-related macular degeneration
Conditions
Interventions
Trade Name: Rescula ophthalmic solution 0.15%
Product Name: Unoprostone Isopropyl
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Unoprostone Isopropyl
CAS Number: 120373-24-2
Other descriptive name: UF-021
Concentration unit: mg/ml
Sponsors
Sucampo Pharma Americas, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the pharmacodynamics of ocular blood flow (time course and maximum effect) measurements with multiple drop unoprostone (Isopropyl) vs Placebo;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint will be choroidal blood flow as assessed by Laser Doppler Flowmetry. | — |
Countries
Austria
Outcome results
None listed