Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery (SAFARI4)

Ciliatech

Status: Enrolling

Conditions: Glaucoma, Narrow Angle; Glaucoma, Open-Angle

Treatments: Device: Cilioscleral Interposition Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05625958

SAFARI 4

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open and narrow angle glaucoma who have failed at least one class of topical medical therapy

Full description

29 patients will be included in this 36 months interventional study.

All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a simplified surgical technique allowing the placement of an interposition supraciliary permanent device.

Several patient data like safety events, IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Enrollment: 29 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria To be included in the study, all patients must meet all the following inclusion criteria:

Patient:

1. 18 years or older

2. Able to understand study requirements

3. Able and willing:

   1. To provide written consent on the EC-approved Informed Consent Form,
   2. To comply with all study requirements, including required study follow-up visits' agenda

   Eye:

4. Glaucoma (angle from 1 to 4 according to Schaffer grade), including pseudo exfoliative and pigmentary glaucoma, which meets the following:

   1. Vertical C/D ratio on fundoscopic exam ≤ 0.9, or OCT demonstrating a thinness of the nerve fibre layer at the p<5% level as defined by the instrument's built-in age-adjusted normative database,
   2. Glaucoma visual field with -15 < MD < 0dB (Humphrey) or 0 < MD < 15 dB (Octopus)

5. Pharmacological treatments: glaucoma not adequately controlled by 1 to 3 different IOP-lowering medication(s), given each for at least one month prior to Screening,

6. IOP:

   1. if using 1 or 2 IOP-lowering medications, IOP is between 18 mmHg and 30 mmHg in the study eye at Screening visit
   2. if using 3 IOP-lowering medications, IOP is between 18 mmHg and 25 mmHg in the study eye at Screening visit

7. Having the indication for glaucoma surgery alone (no concomitant cataract surgery)

8. Central Corneal Thickness between 480 to 620 µm

9. Gonioscopy confirming normal angle anatomy at site of implantation. Angle anatomy may include Peripheral Anterior Synechiae (PAS) of up to maximum of 3 clock hours if not present parallel to the proposed site of device implantation.

Exclusion criteria Patients will not participate in this clinical study if they meet any of the following criteria:

Patient:

1. Patient with a known allergy to any of the constituents of the products used in this study or known steroid responder

2. Patient already included in another study

3. A person protected by law (temporary or permanent guardianship) or not capable of discernment

4. Patient who may not assist to all follow-up visits (because of frequent travelling, or living in remote area, or limited moving capacities, …)

5. Pregnant or nursing woman at the date of inclusion (only for women of childbearing potential: positive urine pregnancy test at screening)

6. With uncontrolled systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent the subject from completing all study visits (e.g. inability to reliably complete visual field testing over the course of the study, or take glaucoma medications (e.g. Parkinson's disease), or uncontrolled systemic disease (diabetes, hypertension) that could compromise participation in the study, …)

7. Who have a new or modified prescription for a systemic treatment that could influence IOP within one month prior to inclusion, or who are aware of a future change in their systemic treatment, or if their medical condition indicates that their systemic treatment may change in the future

8. Chemotherapy in the last 6 months before surgery

   Eye:

9. Inflammatory, congenital, malignant, traumatic, uveitic, neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)

10. Fast progressing or very severe glaucoma or any condition requiring a filtering surgery

11. History of any incisional glaucoma surgery or implantable glaucoma device

12. Prior SLT, ALT or MLT

13. Eye surgery (other than glaucoma) less than 6 months ago, or presenting sequelae of previous eye surgery or trauma

14. Eye with uncontrolled IOP despite 4 IOP-lowering medications prescribed for more than a month

15. Eye with severe OSD and / or severe dry eye defined as Oxford score ≥ 4

16. Inability to obtain accurate IOP measurement throughout the study (e.g. history of corneal surgery, corneal opacities or disease/pathology)

17. Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge Weber syndrome, orbital tumors, orbital congestive disease

18. Any known ocular condition that may require intraocular intervention during the protocol required follow-up period

19. Premature or mature cataract (initial cataract are accepted)

20. Any condition that prevents the investigational device implantation in the superior and nasal region of the eye

21. Pre-existing ocular or systemic pathology that may, in the opinion of the Investigator, cause post-operative complications

22. Non laser retinal surgery

23. Previous cyclodestructive or scleral buckling procedure

24. History of complicated cataract surgery (as posterior capsular rupture, vitreous loss)

25. History of silicone oil

26. Ocular steroid in the planned study eye or systemic steroid use in the last 3 months before surgery

27. Use of oral hypotensive glaucoma medications for treatment of the fellow eye

28. Axial length <20 mm

29. Severe myopia defined as spherical correction < -8 Diopters

30. Best corrected distant visual acuity of 0.1 (20/200) or worse in the study or fellow eye

31. Peripheral synechia at the angle

32. Closed angle

33. Peripheral laser iridotomy in the last 7 days before planned surgery

34. Epithelial or fibrous downgrowth

35. Any kind of endothelial dystrophy

36. Severe blepharitis

37. Chronic or recurrent uveitis

38. Conjunctiva showing keratitis, fine conjunctiva, erosion or abnormal vascularisation

39. Active iris neovascularization, rubeosis, proliferative retinopathy, diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders), vitreous haemorrhage, preretinal haemorrhage, choroidopathy or other ophthalmic disease that could confound study results

40. Scleral fixation IOL

41. Lens dislocation or subluxation

42. Vitreous loss in the anterior chamber

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Cilioscleral Interposition Device

Experimental group

Description:

Any patients corresponding to inclusion / exclusion criteria

Treatment:

Device: Cilioscleral Interposition Device