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Clinical Trials

Retina Specialty Institute is a renowned ophthalmology practice that proudly serves patients across Northwest Florida, Central Florida, Mississippi, and the Alabama Gulf Coast. Our esteemed, skilled eye doctors provide transformative retina care in all aspects of service—from personalized treatments to advanced techniques to state-of-the-art surgical procedures. RSI is the trusted partner of countless people across the US looking to protect and enhance their vision.

As part of our commitment to continued advancement and innovation in the ophthalmology field and eye/retina treatment, our practice offers clinical trials on an ongoing basis. Learn more about our current clinical trials below and contact us now for any questions or to book an appointment with a physician.

Macular Degeneration Clinical Trials View +

RTE888-E001
Neovascular (wet) Age-Related Macular Degeneration (NOVA-1) study – Phase 2; To evaluate the effect and durability of AR-14034 SR (340 μg and 680 μg) on best-corrected visual acuity (BCVA) compared with intravitreal standard of care anti-vascular endothelial growth factor (anti-VEGF) treatment in subjects with nAMD

Sponsor: Alcon/Aerie
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Open to enrollment

Inquire About Enrollment

OPT-302-1004
A Phase 3, Multicenter, Double-Masked, Randomized Study to evaluate the Efficacy and safety of Intravitreal OPT-302 in combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)

Sponsor: Opthea Limited
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Enrollment is closed

CLS1002-202
ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants with Neovascular Age-Related Macular Degeneration

Sponsor: Clearside Biomedical
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

QA102-CS201
A Phase 2, Double-Masked, Randomized, Placebo-Controlled, Dose-Response Study Assessing The Safety And Efficacy Of Qa102 In Subjects With Dry Age-Related Macular Degeneration (Amd)

Sponsor: Smilebiotek Zhuhai Limited
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

ISEE2009
An Open Label Extension (Ole) Phase 3 Trial To Assess The Safety Of Intravitreal Administration Of Avacincaptad Pegol (Complement C5 Inhibitor) In Patients With Geographic Atrophy Who Previously Completed Phase 3 Study Isee2008 (Gather2)

Sponsor: IVERIC bio, Inc
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

EYP-1901-201
A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects with Wet AMD

Sponsor: EyePoint Pharmaceuticals, Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

MR41927
Real-World, Long-Term Data Collection To Gain Clinical Insights Into Roche Ophthalmology Products (VOYAGER STUDY)

Sponsor: Hoffmann-La Roche
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Enrollment is closed

ANX007-GA-01
A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Masked, 4-Arm, Sham-Controlled Study of the Efficacy, Safety, and Tolerability of ANX007 Administered by Intravitreal Injection in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Sponsor: Annexon, Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

GR42691
A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of Faricimab In Patients With Neovascular Age-Related Macular Degeneration (AVONELLE-X)

Sponsor: Hoffmann-La Roche
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

GR40549
A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of The Port Delivery System With Ranibizumab In Patients With Neovascular Age-Related Macular Degeneration (PORTAL)

Sponsor: Hoffmann-La Roche
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

GR42558
A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of Intravitreal Injections Of FHTR2163 In Patients With Geographic Atrophy Secondary To Age Related Macular Degeneration

Sponsor: Genentech, Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

GR40973
A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study To Assess Safety, Tolerability, And Efficacy Of Intravitreal Injections Of FHTR2163 In Patients With Geographic Atrophy Secondary To Age-Related Macular Degeneration (Gallego)

Sponsor: Genentech, Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

ML43000
A Phase IV, Multicenter, Open-Label, Single-Arm Study Of The Response To Treatment After Transition To The Port Delivery System With Ranibizumab (Susvimo™ [Ranibizumab Injection]) In Patients With Neovascular Age-Related Macular Degeneration Previously Treated With Intravitreal Agents Other Than Ranibizumab

Sponsor: Genentech, Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

KS301P107
A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)

Sponsor: Kodiak Sciences Inc
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

20968
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

Sponsor: Bayer
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

Apl2-Ga-305
A Phase 3, Open-Label, Multicenter, Extension Study To Evaluate The Long-Term Safety And Efficacy Of Pegcetacoplan In Subjects With Geographic Atrophy Secondary To Age-Related Macular Degeneration

Sponsor: Apellis Pharmaceuticals, Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

ISEE2008
A Phase 3, Multicenter, Randomized, Double Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration

Sponsor: IVERIC bio, Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

Inherited Retinal Diseases Clinical Trials View +

OPH2005
A Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects with Autosomal Recessive Stargardt Disease

Sponsor: IVERIC bio, Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

NTXMCO-002
A Phase 2b Randomized, Double-Masked, Sham-Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of a Single Intravitreal Injection of vMCO-010 Optogenetic Therapy in Subjects with Advanced Retinitis Pigmentosa [RESTORE]

Sponsor: Nanoscope Therapeutics Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

Diabetic Retinopathy Clinical Trials View +

BP41321
A Randomized, Double-Masked, 48-Week, Parallel Group, Placebo-Controlled Proof Of Concept Study To Investigate The Efficacy And Safety Of Rg7774 In Patients With Diabetes Mellitus Type 1 Or Type 2 With Treatment Naïve Diabetic Retinopathy

Sponsor: Hoffmann-La Roche
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

GR41675
A Phase III, Multicenter, Randomized Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Patients With Diabetic Retinopathy (PAVILION)

Sponsor: Nanoscope Therapeutics Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment Closed

Diabetic Macular Edema Clinical Trials View +

GR41987
A Multicenter, Open-Label Extension Study To Evaluate The Long-Term Safety And Tolerability Of Faricimab In Patients With Diabetic Macular Edema

Sponsor: Hoffmann-La Roche
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment Closed

GR40550
A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study Of The Efficacy, Safety, And Pharmacokinetics Of The Port Delivery System With Ranibizumab In Patients With Diabetic Macular Edema

Sponsor: Hoffmann-La Roche
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is Closed

KS301P103
A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Sponsor: Kodiak Sciences Inc
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is Closed

KS301P104
A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared with Intravitreal Aflibercept in Participants with Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)

Sponsor: Kodiak Sciences Inc
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

4D-150-C002A
Phase 2 Randomized, Active-Controlled, Double-masked Trial of Intravitreal 4d-150 Gene Therapy in Adults with Diabetic Macular Edema (Spectra).

Sponsor: 4D Molecular Therapeutics
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

Retinal Vein Occlusion Clinical Trials View +

22153
Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg With Macula Edema due to Retinal Vein Occlusion.

Sponsor: Bayer-AG
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

 

Retinal Detachments Clinical Trials View +

ONL1204-RRD-002
A Phase 2, Randomized, Sham-Controlled, Single-Masked, Dose-Ranging, Multi-Center Study to Assess the Safety and Efficacy of Intravitreal ONL1204 Ophthalmic Solution in Subjects with Macula-Off Rhegmatogenous Retinal Detachment.

Sponsor:
ONL Therapeutics, Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Active – Enrollment is closed

Stem Cell Research Clinical Trials View +

7317—CL-0003
A Phase 1b, Multicenter, Dose Escalation, Evaluation of Safety and Tolerability of ASP7317 for Geographic Atrophy Secondary to Age-related Macular Degeneration.

Sponsor: Astellas Institute for Regenerative Medicine
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Open to enrollment

Inquire About Enrollment

Gene Therapy Clinical Trials View +

81201887MDG2001
A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887 (AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Sponsor: Janssen Research & Development, LLC
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Open to enrollment

Inquire About Enrollment

RGX-314-2104
A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants with nAMD (ATMOSPHERE)

Sponsor: REGENXBIO Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Open to enrollment

Inquire About Enrollment

RGX-314-3101
A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study To Evaluate The Efficacy And Safety Of Rgx-314 Gene Therapy In Participants With nAMD

Sponsor: REGENXBIO Inc.
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Open to enrollment

Inquire About Enrollment

4D-15-C001
A Phase 1/2 Dose-Escalation and Randomized, Controlled, Masked Expansion Trial of Intravitreal 4D-150 Gene Therapy in Adults with Neovascular (Wet) Age-Related Macular Degeneration

Sponsor: 4D Molecular Therapeutics
Principal Investigator: Sunil Gupta, MD
Clinicaltrials.gov
Status: Open to enrollment

Inquire About Enrollment

Clinical Trials FAQ

What is a clinical trial?

What are the benefits of participating in a clinical trial?
Reasons a patient may partake in a clinical trial may include:

  • Potential benefits from a new drug or treatment
  • Better methods for managing their symptoms
  • Contributing to better future care for others

What clinical trials or enrolling studies are available at Retina Specialty Institute?

We engage in clinical trials that we feel will best advance the health needs of our patients, with special interest in those striving to impact leading causes of blindness:

  • Age-Related Wet Macular Degeneration (Wet AMD)
  • Diabetic Macular Edema/Diabetic Retinopathy (DME)
  • Retinal Vein Occlusion (BRVO/CRVO)

How are clinical trials conducted?

Each clinical trial has a number of steps, which are known as phases. Each phase focuses on answering a specific research question.

  • Phase I: This first phase of a clinical trial involves only a small group of people. During Phase I, researchers are focused on the safety of a drug or treatment.
  • Phase II: Phase II of a clinical trial is also focused on safety, but this time the drug or treatment is given to a larger group of people.
  • Phase III: In Phase III of a clinical trial, research is conducted with even larger groups of people. This part of the trial focuses on the effectiveness of a drug or treatment while monitoring side effects. At this time, the drug or treatment is also compared to commonly used treatments and additional information is collected to allow for safe use of the drug or treatment.
  • Phase IV: Phase IV is conducted after a drug or treatment is already on the market. At this time, additional information can be gathered regarding how the drug affects a broader patient population and long-term side effects are evaluated.

Are all clinical trials effective?

Clinical trials provide patients either a promising new treatment or the best available conventional treatment. It is impossible to guarantee the success of a treatment. However, clinical trials have been proven to offer some of the most advanced retinal treatments available today.

Contact Retina Specialty Institute

To learn more about clinical trials, including whether you are a good candidate for an ongoing clinical trial, please complete the form below to join our research registry. You can also contact our Study Coordinator, Sarah Faruzzi, directly at sfaruzzi@retinaspecialty.com or call (850) 476-6759 x 940 with any clinical research related questions.

 

Clinical Trials
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The doctors at Retina Specialty Institute have either authored or reviewed and approved this content.

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