E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vitreomacular Traction/ Symptomatic Vitreomacular Adhesion |
Trazione vitreomaculare/adesione vitreomaculare sintomatica |
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E.1.1.1 | Medical condition in easily understood language |
Vitreomacular Traction/ Symptomatic Vitreomacular Adhesion |
Trazione vitreomaculare/adesione vitreomaculare sintomatica |
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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 | 16.1 |
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 | 16.1 |
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 |
To observe the anatomical and functional outcomes of ocriplasmin over a
6-month follow-up period |
osservare gli esiti anatomici e funzionali dell’ocriplasmina per un periodo di sei mesi |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Non applicabile |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Ages Eligible for Study: 18 Years and older
- Genders Eligible for Study: Both
- Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMT visible on Spectral Domain Optical Coherence Tomography (SD-OCT).
- Read, sign, and date an Institutional Review Board/Ethics Committeeapproved informed consent form.
- Other protocol-defined inclusion criteria may apply. |
1.Almeno 18 anni di età al momento del rilascio del consenso informato
2.Diagnosi di VMT/sVMA, con evidenza di VMT focale osservabile mediante SD-OCT.
3.Un modulo di consenso informato approvato dal Comitato Etico letto, firmato e datato dal soggetto partecipante.
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E.4 | Principal exclusion criteria |
- Women of childbearing potential if pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- Hypersensitivity to ocriplasmin or any of the Jetrea excipients
- Active or suspected intraocular or periocular infection
- Presence of Epiretinal Membrane (ERM) over the macula at baseline
- Broad VMT/VMA >1500 microns at Baseline
- History of vitrectomy in the study eye
- History of laser photocoagulation to the macula in the study eye
- Any relevant concomitant ocular condition that, in the opinion of the investigator, could be expected to worsen or require surgical intervention during the study period
- Macular hole of >400μm diameter in the study eye
- High myopia in study eye
- Pseudo-exfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens/zonular instability.
- Therapy with another investigational agent within 30 days prior to Visit 1.
- Active, simultaneous enrollment in another ophthalmology clinical study.
- Other protocol-defined exclusion criteria may apply |
1.I soggetti di sesso femminile in età fertile (che non siano in post-menopausa da almeno 1 anno o chirurgicamente sterili) sono esclusi se:
a. sono attualmente in stato di gravidanza,
b. risultano positivi al test di gravidanza sulle urine alla Visita 1,
c. intendono iniziare una gravidanza durante lo studio,
d. allattano al seno, oppure
e. non acconsentono a usare metodi contraccettivi adeguati per prevenire la gravidanza durante tutto lo studio.
2. Ipersensibilità all’ocriplasmina o ad uno qualsiasi degli eccipienti di JETREA
3. Infezioni intraoculari o perioculari attive o sospette
4. Presenza di membrana epiretinica (ERM) sopra la macula al basale.
5. VMT/VMA estesa > 1.500 micron al basale.
6. Anamnesi di vitrectomia nell’occhio oggetto di studio.
7. Anamnesi di fotocoagulazione laser alla macula nell’occhio oggetto di studio.
8. Qualsiasi rilevante condizione oculare concomitante che, a giudizio dello sperimentatore, è prevedibile peggiori o richieda un intervento chirurgico durante il periodo di studio.
9. Foro maculare con diametro > 400 µm nell’occhio oggetto di studio.
10. Miopia elevata nell’occhio oggetto di studio
11. Pseudoesfoliazione, sindrome di Marfan, facodonesi o qualsiasi altro risultato che a giudizio dello sperimentatore suggerisca un’instabilità del cristallino/zonulare.
12. Terapia con un altro agente sperimentale entro 30 giorni prima della Visita 1.
13. Arruolamento attivo concomitante in un altro studio clinic di oftalmologia
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with nonsurgical resolution of focal vitreomacular traction (VMT/sVMA), as determined by Central Reading Center (CRC) SD-OCT evaluation |
Percentuale di soggetti con risoluzione non chirurgica della trazione vitreomaculare (VMT/sVMA) focale il Giorno 28, determinata mediante valutazione basata su SD-OCT [Spectral Domain Optical coherence tomography, (tomografia a coerenza ottica nel dominio spettrale)] condotta presso il Centro di lettura centrale (Central Reading Center, CRC). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Changes in best-corrected visual acuity (BCVA) at distance compared to Baseline
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 in central foveal thickness compared to Baseline |
1. Variazioni nella migliore acuità visiva corretta (best-corrected visual acuity, BCVA) a distanza rispetto al basale.
2.Percentuale di soggetti con chiusura del foro maculare (macular hole, MH) (se presente al basale).
3.Percentuale di soggetti con risoluzione non chirurgica della VMT/sVMA.
4.Percentuale di soggetti sottoposti a una vitrectomia via pars plana (Pars Plana vitrectomy, PPV)
5. Variazione nello spessore foveale centrale rispetto al basale.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Baseline, Days 28, 90 and 180
2. Baseline, Days 28, 90 and 180
3. Days 90 and 180
4. Day 180
5. Baseline, Days 28 and 180 |
1. Basale, giorni 28, 90 e 180
2. Basale, giorni 28, 90 e 180
3. Giorni 90 e 180
4. Giorno 180
5. Basale, giorni 28 e 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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 83 |
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 |
Belgium |
Canada |
France |
Italy |
Netherlands |
Portugal |
Germany |
Hungary |
Spain |
Poland |
United Kingdom |
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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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |