E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PRM-151, a novel agent, is being developed for potential therapeutic uses to prevent, treat and reduce fibrosis. This study will investigate the ability of PRM-151 to prevent scarring post glaucoma filtration surgery (trabeculectomy). |
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E.1.1.1 | Medical condition in easily understood language |
Study will investigate the ability of PRM-151 to prevent scarring post glaucoma filtration surgery. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018304 |
E.1.2 | Term | Glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to assess the safety and tolerability of PRM-151 administered as a subconjunctival injection in glaucoma patients who have undergone primary trabeculectomy. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to explore the activity of PRM-151 compared to placebo on the success of trabeculectomy by reducing post-surgical scarring in glaucoma patients who have undergone primary trabeculectomy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men or women of nonchildbearing potential (WONCBP) aged 18 years and older at screening. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with follicle stimulating hormone [FSH] ≥38 mIU/mL) and must have a negative pregnancy test result at screening. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound. Sexually active men must agree to use a medically acceptable form of contraception during the study.
2. Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma. For pseudophakic glaucoma patients, the cataract surgery performed was with phacoemulsification and through a corneal incision.
3. Suitable candidate for trabeculectomy in the study eye which the physician deems as medically necessary. |
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E.4 | Principal exclusion criteria |
1. Diagnosis of glaucoma other than chronic angle-closure glaucoma or open-angle glaucoma (ie., uveitic, traumatic or neovascular glaucoma).
2. Any previous ocular surgeries in the study eye involving the upper conjunctiva and sclera.
3. History of laser surgeries in the study eye within 90 days before day 1.
4. Presence or history of any disease that could affect wound healing.
5. Any asymmetric abnormality of the anterior segment which requires additional intervention (surgery or medication).
6. Any abnormality other than glaucoma in the study eye that could affect tonometry.
7. Presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1.
8. Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.
9. Clear corneal phacoemulsification performed within 90 days before day 1.
10. Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
11. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article or the assessment of the effect of the test article.
12. History of drug abuse or alcohol abuse within 1 year before screening that may interfere with the subject’s ability to comply with the protocol requirements.
13. Conjunctival scarring precluding a trabeculectomy.
14. Vitreous in the anterior chamber.
15. Proliferative retinopathy.
16. Abnormality preventing reliable applanation tonometry in each eye.
17. History of drug anaphylaxis to any of the test articles used in this study.
18. Hemodialysis.
19. Use of any anti-scarring ophthalmologic agents within 90 days before day 1.
20. Use of antimetabolites or systemic steroids within 90 days before day 1.
21. Treatment with cancer chemotherapy within 30 days before day 1.
22. Use of any investigational drug within 30 days before day 1. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The exploratory endpoints will be summarized statistically for the ITT
population as well as the per-protocol population. Categorical entpoints
will be summarized using counts and percentages. Continuous or ordinal
data will be summarized using descriptive statistics. Several endpoints
will be evaluated to assess the prevention of postoperative scarring.
- Successfull IOP control at day 120
- Change from baseline IOP
- Percent change from baseline IOP
- Bleb scarring as assessed by OCT
- Parameters of Moorfields bleb grading scale
- Trabeculectomy failure rate
- Number of IOP-lowering medications taken per subject |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 120, Day 180, Day 360 |
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E.5.2 | Secondary end point(s) |
none - all endpoints are exploratory |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 14 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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The end of the trial will be the last visit of the last patient. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |