ACTIVE CLINICAL TRIALS

SEER-2 (RGN-NK-302) — Neurotrophic Keratopathy Study

Sponsor: ReGenTree, LLC

Disease: Neurotrophic Keratopathy

Purpose: This study is evaluating whether an investigational drug called RGN-259 (Thymosin Beta 4) eye drops solution is a safe and effective option for the treatment of neurotrophic keratopathy.

ClinicalTrials.gov: NCT05555589 — a Phase 3, multi-center, randomized, parallel, double-masked, placebo-controlled study to assess the safety and efficacy of 0.1% RGN-259 ophthalmic solution for the treatment of neurotrophic keratopathy (SEER-2).

To enroll in this study, please contact Susan Sherouse via ssherous@usf.edu or (813) 974-0948.

CURRENTLY ENROLLING

RTI #25-RX23 — Neurotrophic Keratopathy / Ocular Surface Disease Study

Sponsor: Alcon

Disease: Stage I Neurotrophic Keratopathy with Tear Deficiency (Ocular Surface Disease)

Purpose: This study is evaluating the effect of acoltremon ophthalmic solution 0.003% on signs and symptoms of ocular surface disease in stage I neurotrophic keratopathy patients with tear deficiency.

ClinicalTrials.gov: NCT07502378 — study evaluating acoltremon ophthalmic solution 0.003%.

To enroll in this study, please contact Angie Windham via angiewindham@usf.edu or (813) 974-1423.

CURRENTLY ENROLLING

Cenegermin for Persistent Corneal Epithelial Defect (PCED)

Sponsor: Dompé Farmaceutici S.p.A.

Disease: Persistent Corneal Epithelial Defect (PCED)

Purpose: This study is evaluating the safety and effectiveness of cenegermin eye drops to help heal persistent corneal surface defects.

ClinicalTrials.gov: NCT07519902 — a Phase 3, randomized, multicenter, double-masked, vehicle-controlled study of cenegermin ophthalmic solution vs vehicle for persistent corneal epithelial defect (PCED).

To enroll in this study, please contact Susan Sherouse via ssherous@usf.edu or (813) 974-0948.

CURRENTLY ENROLLING

UPCOMING CLINICAL TRIALS

GLK-601-01 — Persistent Corneal Epithelial Defect Study

Sponsor: Glaukos Corporation

Disease: Persistent Corneal Epithelial Defects (PCED)

Purpose: This study is evaluating an investigational ophthalmic gel designed to promote healing of persistent corneal defects.

ClinicalTrials.gov: NCT05966493 — a Phase 2, randomized, multicenter, double-masked, vehicle-controlled study of NEXAGON® (lufepirsen ophthalmic gel) vs vehicle for persistent corneal epithelial defects (PCED).

To enroll in this study, please contact our research department at (813) 974-2020 to be connected with a coordinator.

COMING SOON – UPCOMING STUDY

TRS-028 — Capellion Study

Sponsor: Tarsus Pharmaceuticals, Inc.

Disease: Persistent Corneal Epithelial Defects (PCED)

Purpose: This study is evaluating the safety and effectiveness of TP-06, an investigational ophthalmic solution, in patients with persistent corneal epithelial defects.

ClinicalTrials.gov: NCT05348577 — a Phase 3 study (details to confirm) for a separate condition; this placeholder will be updated once the correct TRS-028 / TP-06 ClinicalTrials.gov ID is confirmed.

To enroll in this study, please contact our research department at (813) 974-2020 to be connected with a coordinator.

COMING SOON – UPCOMING STUDY

PUTT – Parasitic Ulcer Treatment Trial

Sponsor: National Eye Institute (NEI)

Disease: Acanthamoeba Keratitis

Purpose: This study is evaluating whether adding steroid eye drops may improve healing and vision outcomes in patients with acanthamoeba keratitis.

ClinicalTrials.gov: NCT06213649 — a Phase 3, multi-center, parallel-group, randomized clinical trial (PUTT) evaluating topical corticosteroids vs topical placebo as adjunctive therapy for acanthamoeba keratitis.

To enroll in this study, please contact our research department at (813) 974-2020 to be connected with a coordinator.

COMING SOON – UPCOMING STUDY

TS-NK-001 — Neurotrophic Keratitis Study

Sponsor: TearSolutions, Inc.

Disease: Neurotrophic Keratitis

Purpose: This study is evaluating the safety and effectiveness of Lacripep ophthalmic solution for improving the ocular surface and corneal health in patients with neurotrophic keratitis.

ClinicalTrials.gov: NCT07568730 — a Phase 2, multicenter, randomized, vehicle-controlled study evaluating lacripep ophthalmic solution for neurotrophic keratitis.

To enroll in this study, please contact our research department at (813) 974-2020 to be connected with a coordinator.

COMING SOON – UPCOMING STUDY

ICY-DED-201 — Dry Eye Disease Study

Sponsor: Dompé Farmaceutici S.p.A.

Disease: Dry Eye Disease

Purpose: This study is evaluating the safety and effectiveness of DFL24498 ophthalmic solution for patients with dry eye disease.

ClinicalTrials.gov: NCT07503886 — a Phase 2, randomized, multicenter, double-masked, vehicle-controlled study of DFL24498 topical ophthalmic solution vs vehicle in dry eye disease.

To enroll in this study, please contact our research department at (813) 974-2020 to be connected with a coordinator.

COMING SOON – UPCOMING STUDY

ACTIVE CLINICAL TRIALS

Sienna (R3918-AMD-2326) — Geographic Atrophy Study

Sponsor: Roche (R3918)

Disease: Geographic Atrophy Secondary to Age-Related Macular Degeneration

Purpose: This study is evaluating a subcutaneous treatment for geographic atrophy (pozelimab in combination with cemdisiran, or cemdisiran alone).

ClinicalTrials.gov: NCT0654170 — a multicenter, randomized, double-masked, placebo-controlled Phase 3 study in geographic atrophy secondary to AMD.

To enroll in this study, please contact Susan Sherouse via ssherous@usf.edu or (813) 974-0948.

CURRENTLY ENROLLING

UPCOMING CLINICAL TRIALS

M24-528 for Wet AMD

Sponsor: AbbVie Inc.

Disease: Neovascular (Wet) Age-Related Macular Degeneration (nAMD)

Purpose: This study is evaluating a gene therapy designed to reduce injection burden while preserving vision in patients with wet AMD.

ClinicalTrials.gov: NCT07007065 — a Phase 3b, randomized, controlled study evaluating surabgene lomparvovec (ABBV-RGX-314) for neovascular (wet) age-related macular degeneration (nAMD).

To enroll in this study, please contact our research department at (813) 974-2020 to be connected with a coordinator.

COMING SOON – UPCOMING STUDY

Gallop (APL-3007) for Geographic Atrophy

Sponsor: Apellis Pharmaceuticals, Inc.

Disease: Geographic Atrophy Secondary to Age-Related Macular Degeneration

Purpose: This study is evaluating the safety and effectiveness of APL-3007 in combination with SYFOVRE® for geographic atrophy.

ClinicalTrials.gov: __ — a Phase 1b/2 study (planned) evaluating APL-3007 (siRNA) in combination with SYFOVRE® (pegcetacoplan) for geographic atrophy secondary to AMD.

To enroll in this study, please contact our research department at (813) 974-2020 to be connected with a coordinator.

COMING SOON – UPCOMING STUDY

UPCOMING CLINICAL TRIALS

NGF-NAION-301 — NAION Study

Sponsor: Dompé Farmaceutici S.p.A.

Disease: Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Purpose: This study is evaluating intranasal cenegermin as a potential treatment to improve vision and optic nerve health in adults with NAION.

ClinicalTrials.gov: NCT07453888 — a Phase 3, randomized, multicenter, vehicle-controlled, double-masked study evaluating intranasal cenegermin in adults with NAION.

To enroll in this study, please contact our research department at (813) 974-2020 to be connected with a coordinator.

COMING SOON – UPCOMING STUDY

ARGX-113-2301 — Thyroid Eye Disease Study

Sponsor: Argenx BV

Disease: Thyroid Eye Disease (TED)

Purpose: This study is evaluating the safety and effectiveness of efgartigimod injections in adults with thyroid eye disease.

ClinicalTrials.gov: NCT06307613 — a Phase 3, randomized, double-masked, placebo-controlled, multicenter study evaluating efgartigimod PH20 SC in adults with thyroid eye disease.

To enroll in this study, please contact our research department at (813) 974-2020 to be connected with a coordinator.

COMING SOON – UPCOMING STUDY

UPCOMING TRIALS

IDE196-010 — OptimUM-10 Uveal Melanoma Study

Sponsor: IDEAYA Biosciences, Inc.

Disease: Primary Non-Metastatic Uveal Melanoma

Purpose: This study is evaluating darovasertib as a treatment option before standard therapy for patients with uveal melanoma.

ClinicalTrials.gov: __ — a Phase 3, randomized, multi-center, open-label neoadjuvant darovasertib study in primary non-metastatic uveal melanoma (OptimUM-10). (NCT07015190)

To enroll in this study, please contact our research department at (813) 974-2020 to be connected with a coordinator.

COMING SOON – UPCOMING STUDY

ACTIVE CLINICAL TRIALS

ATS22 — Amblyopia (Sequential vs Simultaneous Patching)

Sponsor: Jaeb Center for Health Research

Disease: Amblyopia (children 3 to 13)

Purpose: This study is evaluating whether simultaneous treatment with spectacles and patching has an equivalent visual acuity outcome compared with sequential treatment (spectacles alone followed by patching if needed) in previously untreated amblyopia.

ClinicalTrials.gov: NCT04378790 — A randomized trial to evaluate sequential vs simultaneous patching (ATS22).

To enroll in this study, please contact Susan Sherouse via ssherous@usf.edu or (813) 974-0948.

CURRENTLY ENROLLING

ATS23 — Amblyopia (Dichoptic Movies/Shows vs Patching)

Sponsor: Jaeb Center for Health Research

Disease: Amblyopia (children 4 to 7)

Purpose: This study is evaluating whether 1 hour per day, 6 days per week of watching dichoptic movies/shows using the Luminopia headset is non-inferior to 2 hours of patching per day, 7 days per week, for improving amblyopic eye distance visual acuity.

ClinicalTrials.gov: NCT06380517 — Dichoptic treatment for amblyopia in children 4 to 7 years of age (ATS23).

To enroll in this study, please contact Susan Sherouse via ssherous@usf.edu or (813) 974-0948.

CURRENTLY ENROLLING

ATS24 — Amblyopia (Luminopia vs Vivid Vision)

Sponsor: Jaeb Center for Health Research

Disease: Amblyopia (children 8 to 12)

Purpose: This study is comparing the effectiveness of Luminopia and Vivid Vision while wearing optical correction.

ClinicalTrials.gov: NCT06524882 — a randomized trial of dichoptic treatment for amblyopia in children 8 to 12 (ATS24).

To enroll in this study, please contact Susan Sherouse via ssherous@usf.edu or (813) 974-0948.

CURRENTLY ENROLLING