Safety and Efficacy of HydroLenz for Vitrectomy-Induced Lens Opacities

NCT05592912 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: HL-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pars Plana Vitrectomy

Outcome Measures

Primary Outcomes (4)

• Evaluation of Changes in Lens Opacities

  The Lens Opacity Classification System, Version III (LOCS III) and the rate of lens related (cataract) surgery will be used to evaluate the lens opacities.

  Baseline and 6 Months

• Evaluation of Changes in Lens Opacities

  The Lens Opacity Classification System, Version III (LOCS III) and the rate of lens related (cataract) surgery will be used to evaluate the lens opacities.

  Baseline and 12 Months

• Changes in BSCVA

  Number of eyes losing more than 2 lines of BSCVA

  Baseline and 6 Months

• Changes in BSCVA

  Number of eyes losing more than 2 lines of BSCVA

  Baseline and 12 Months

Study Arms (3)

Low dose HydroLenz treatment

EXPERIMENTAL

Drug: HydroLenz Injection

High dose HydroLenz treatment

EXPERIMENTAL

Drug: HydroLenz Injection

Control, i.e., no HydroLenz treatment

PLACEBO COMPARATOR

Other: No HydroLenz Injection

Interventions

HydroLenz Injection DRUG

The HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day

High dose HydroLenz treatment; Low dose HydroLenz treatment

No HydroLenz Injection OTHER

No HydroLenz injection will be administered at the conclusion of the vitrectomy procedure on the operative day.

Control, i.e., no HydroLenz treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male or female of any race.
• years of age or older.
• Study eye is phakic and scheduled for pars plana vitrectomy (23, 25, or 27 gauge) for epiretinal membrane or vitreomacular traction surgery.
• Willingness and ability to comply with schedule for follow-up visits.
• 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.

You may not qualify if:

• Aphakic or pseudophakic lens status in either or both eyes.
• History of previous cataract surgery in either eye.
• Evidence of congenital cataract.
• Study eye with corneal opacity of one of the following LOCS III grades or condition that would confound the LOCS III grading results:
• Inability to grade opacities in the study eye with LOCS III at the baseline exam;
• Inability to dilate pupil to at least 6.0 mm;
• LOCS III grade ≥ 2 for nuclear opalescence, cortical lens opacities, or posterior subcapsular lens opacities in the study eye at baseline.
• Diabetic retinopathy or macular edema in the study eye.
• Retinal vascular disease or retinopathy in the study eye.
• History of previous intravitreal injections in the study eye.
• History of previous subconjunctival injections in the study eye.
• History of previous radiation in the study eye.
• History of systemic, periocular, inhaled, or chronic topical corticosteroids.
• Previous laser prophylaxis for retinal tear/hole/lattice degeneration in the study eye.
• Previous pneumatic retinopexy or retinal detachment repair in the study eye.

Sponsors & Collaborators

• PromiSight, LLC: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 25, 2022
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share