E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vitreomacular Traction/ Vitreomacular Adhesion |
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E.1.1.1 | Medical condition in easily understood language |
Vitreomacular Traction/ Vitreomacular Adhesion |
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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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070236 |
E.1.2 | Term | Vitreomacular adhesion |
E.1.2 | System Organ Class | 100000004853 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051065 |
E.1.2 | Term | Vitreomacular traction syndrome |
E.1.2 | System Organ Class | 100000004853 |
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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 |
The objective of this study is to observe the anatomical and functional outcomes of ocriplasmin over a 6 month follow-up period. |
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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. Ages Eligible for study: 18 years and older
2. Diagnosed with VMT/sVMA, with evidence of focal VMT visible on Spectral Domain – Optical Coherence Tomography (SD-OCT)
3. Read, signed, and date an Institutional Review board/Ethics Committeeapproved informed consent form
4. Willing and able to attend all study visits
5. Other protocol-specified inclusion criteria may apply |
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E.4 | Principal exclusion criteria |
1. Women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
2. Hypersensitivity to ocriplasmin or any of the JETREA excipients
3. Active or suspected intraocular or periocular infection in either eye
4. Participation in any interventional clinical trial within 30 days prior to baseline
5. Presence of epiretinal membrane (ERM) over the central macula in the study eye
6. Broad VMT/sVMA > 1500 microns in the study eye
7. History of vitrectomy in the study eye
8. History of laser photocoagulation to the macula in the study eye
9. Any relevant concomitant ocular condition in the study eye that, in the opinion of the Investigator, could be expected to worsen or require surgical intervention during the study period
10. Macular hole of > 400 microns diameter in the study eye
11. High myopia in the study eye
12. Pseudo-exfoliation, Marfan’s syndrome, phacodonesis, or any other finding in the study eye that, in the Investigator’s opinion suggesting lens/zonular instability
13. Aphakia in the study eye
14. History of retinal detachment in the study eye
15. Recent ocular surgery or ocular injection in the study eye within the past 90 days (including laser therapy)
16. Proliferative diabetic retinopathy in the study eye
17. Ischemic retinopathies in the study eye
18. Retinal vein occlusions in the study eye
19. Exudative age-related macular degeneration (AMD) in the study eye
20. Vitreous hemorrhage in the study eye
21. Other protocol-specified exclusion criteria may apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with nonsurgical resolution of focal VMT/sVMA, as determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Changes from baseline in best-corrected visual acuity (BCVA) at distance
2. Proportion of subjects with closure of macular hole (MH) (if present at baseline)
3. Proportion of subjects with nonsurgical resolution of VMT/sVMA
4. Proportion of subjects experiencing Pars plana vitrectomy (PPV)
5. Change from baseline in central foveal thickness |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Days 7, 28, 90 and 180
2. Days 7, 28, 90 and 180
3. Days 7, 90 and 180
4. Day 180
5. Days 28 and 180 |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 11 |
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 | No |
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 |
Australia |
Brazil |
Colombia |
Greece |
Korea, Republic of |
Malaysia |
Mexico |
New Zealand |
Norway |
Singapore |
Sweden |
Taiwan |
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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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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 | 5 |
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 | 5 |