Research and Clinical Trails

Nationally recognized research team committed to moving vision research forward

Ophthalmology- Retinal Disease Studies

ROCHE
GRA1986 (Comino) Follow-Up
PI: Dr. Ghassan Ghorayeb

A Phase III, Multicenter, Randomized, Double-masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients with Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion

The primary objective of this study is to evaluate the efficacy, safety, and pharmacokinetics of faricimab 6mg IVT Q4W compared with aflibercept 2mg IVT Q4W in patients with macular edema due to central retinal or hemiretinal vein occlusion.

ROCHE GENENTECH
GR41987 (RHONE-X) Follow-Up
PI: Dr. Ghassan Ghorayeb
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients with Diabetic Macular Edema

This long-term extension study will evaluate the long-term safety, tolerability, and efficacy of IVT faricimab in patients with diabetic macular edema who have completed either of the Phase III (GR40349 or GR40398) studies.

Ashvattha Therapeutics
D-4517-002 (Tejas) ENROLLING
PI: Dr. Ghassan Ghorayeb

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in subjects with Neovascular (wet) Age-Related Macular Degeneration (AMD) or subjects with Diabetic Macular Edema (DME)

The purpose of this study is to determine the safety and tolerability of a single dose of D-4517.2 and evaluate the relative efficacy of different dose regimens of SC administered D-4517.2 compared to IVT aflibercept in patients with neovascular (wet) AMD and subjects with DME.

Regeneron
VGFTe-HD-DME-1934 (Photon) Follow-Up
PI: Dr. Ghassan Ghorayeb
A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients with Diabetic Macular Edema

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.

Regeneron
BAYER-AG 20968 (Pulsar) Follow-Up
PI: Dr. Ghassan Ghorayeb
Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients with Neovascular Age-Related Macular Degeneration

The primary objective of this study is to determine if treatment with aflibercept 8mg (HD) at intervals of 12 or 16 weeks provides non-inferior BCVA change compared to aflibercept 2mg every 8 weeks in participants with nAMD.

Adverum Biotechnologies
ADVM-022-11 (LUNA) ENROLLING
PI: Dr. Ghassan Ghorayeb
A Multi-Center, Randomized, Double-Masked Phase 2 Study to Assess Safety and Efficacy of ADVM-022 (AAV.7m8-aflibercept) in Anti-VEGF Treatment Experienced Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD) [LUNA]

The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single IVT injection of ADVM-022 at one of two doses (2E11 vg/eye or 6E10 vg/eye) accompanied by one of four prophylactic corticosteroid treatment regimens in patients with neovascular (wet) age-related macular degeneration.

Oxurion
THR-149-002 (Kalahari) ENROLLING
PI: Dr. Ghassan Ghorayeb
A Phase 2, Randomized, Multicentre study to assess the dose level of multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME) [Kalahari]

The primary objectives of this study are to select THR-149 dose level (0.01mg, 0.04mg, or 0.13mg), and assess the treatment effect between the THR-149 selected dose (0.13mg) and aflibercept in patients with diabetic macular edema.

Roche Genentech
GE43220 (Honu) Observational Imaging Study ENROLLING
PI: Dr. Ghassan Ghorayeb
A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

The primary objective of this observational study is to assess iAMD disease progression, by the timeline and rates of conversion for high-risk iAMD at baseline to more advanced atrophic AMD stages, such as nGA or iRORA, and subsequently from nGA or iRORA to cRORA or GA.

Syneos Health
DX219 (Oculis) ENROLLING
PI: Dr. Ghassan Ghorayeb
A Phase 2/3 Double-Masked, Randomized, 2 stage, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema

The primary objectives of this study are to evaluate the safety and efficacy of OCS-01 versus vehicle alone in subjects with DME, and to confirm efficacy and safety of OSC-01 as compared to vehicle at the end of the 52-week treatment period in BCVA assessed with ETDRS scale.

 Regeneron Pharmaceuticals

VGFTe-ROP-2036 (Butterfleye Next) Follow-Up
PI: Dr. Ghassan Ghorayeb
An Extension Study to Evaluate the Long-Term Outcomes of Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study
The primary objectives of this extension study are to evaluate binocular best-corrected visual acuity, proportion of patients with adverse events, and proportion of patients with serious adverse events in patients included from the VGFTe-ROP-1920 study for treatment of retinopathy of prematurity (ROP) up to 5 years of chronological age.

Ophthalmology- Thyroid Eye Disease Studies

VasaraGen, Inc.
VGN-TED-301 ENROLLING
PI: Dr. John Nguyen
A Phase 2b, Randomized, Double-Mask, Placebo Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)
The purpose of this study is to study the effect of two doses (75mg or 150mg) of linsitinib versus placebo on the proptosis responder rate of patients with active, moderate to severe thyroid eye disease (TED).

Immunovant Sciences, GmbH
IMVT-1401-3202 ENROLLING
PI: Dr. John Nguyen
A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
The primary objective of this study is to evaluate the efficacy of batoclimab 680mg subcutaneously (SC) once a week (QW) for 12 weeks followed by 340mg SC QW for 12 weeks versus placebo on proptosis responder rate at week 24.

Ophthalmology- Glaucoma Studies

West Virginia University, University of Pittsburgh
Clarifying the Optimal Application of SLT Therapy (COAST) ENROLLING
PI: Dr. Anthony Realini
The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.