Clinical trial NCT05592912: Safety and Efficacy of HydroLenz for Vitrectomy-Induced Lens Opacities
Official title: Safety and Preliminary Efficacy of Two Dose Levels of HydroLenz as a Protectant for Vitrectomy-Induced Lens Opacities in Subjects Undergoing Vitrectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pars Plana Vitrectomy
Lead sponsor: PromiSight, LLC
Sponsor class: INDUSTRY
First posted: 2022-10-25
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to provide safety data for two different dosages of HydroLenz. Secondary objectives are to provide preliminary data to determine whether HydroLenz has the same effect in humans as it does in the porcine model; to confirm the reliability of methods for evaluating lens opacity; and, to acquire information that can be used to design the pivotal study.


Eligibility criteria: Inclusion Criteria:

1. Male or female of any race.
2. 65 years of age or older.
3. Study eye is phakic and scheduled for pars plana vitrectomy (23, 25, or 27 gauge) for epiretinal membrane or vitreomacular traction surgery.
4. Willingness and ability to comply with schedule for follow-up visits.
5. Subject understands the study requirements and the treatment procedures and provides signed, written informed consent obtained in accordance with the institutional review board (or ethics committee) requirements for this first-in-man early feasibility study.

Exclusion Criteria:

1. Aphakic or pseudophakic lens status in either or both eyes.
2. History of previous cataract surgery in either eye.
3. Evidence of congenital cataract.
4. Study eye with corneal opacity of one of the following LOCS III grades or condition that would confound the LOCS III grading results:

   1. Inability to grade opacities in the study eye with LOCS III at the baseline exam;
   2. Inability to dilate pupil to at least 6.0 mm;
   3. LOCS III grade ≥ 2 for nuclear opalescence, cortical lens opacities, or posterior subcapsular lens opacities in the study eye at baseline.
5. Diabetic retinopathy or macular edema in the study eye.
6. Retinal vascular disease or retinopathy in the study eye.
7. History of previous intravitreal injections in the study eye.
8. History of previous subconjunctival injections in the study eye.
9. History of previous radiation in the study eye.
10. History of systemic, periocular, inhaled, or chronic topical corticosteroids.
11. Previous laser prophylaxis for retinal tear/hole/lattice degeneration in the study eye.
12. Previous pneumatic retinopexy or retinal detachment repair in the study eye.
13. Previous vitrectomy in the study eye.
14. Previous laser treatment anywhere in the study eye (trabecular meshwork, iris, retina, macula).
15. Use of silicone oil, air or gas tamponade during the vitrectomy in the study eye prior to injection of the HydroLenz.
16. Use of binocular indirect ophthalmoscopy laser during the procedure (endolaser is permitted).
17. History of any previous ocular surgery in the study eye.
18. Any ocular trauma resulting in lens opacity or subluxation of the lens in the study eye.
19. Iatrogenic lens trauma during surgery prior to injection of the HydroLenz.
20. Surgical plan for the vitrectomy includes planned glaucoma filtering or tube-shunt procedure or any procedure affecting the lens.
21. Female patients who are pregnant or lactating or plan to become pregnant during the course of the study.
22. A known sensitivity to study medications for which no alternative medication can be - prescribed.
23. Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the HydroLenz treatment or study participation or may confound the outcome of the study.

Primary outcomes:
measure: Evaluation of Changes in Lens Opacities
timeFrame: Baseline and 6 Months
measure: Evaluation of Changes in Lens Opacities
timeFrame: Baseline and 12 Months
measure: Changes in BSCVA
timeFrame: Baseline and 6 Months
measure: Changes in BSCVA
timeFrame: Baseline and 12 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: