Evaluation of results in patients treated with Ocriplasmin for specific eye diseases associated with reduced visio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

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
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 330

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