Clinical Trials
Your participation is valuable.
Your participation in clinical research provides important information, critical to the advancement of medical care for hundreds of thousands of people. It could save the sight of you, your loved ones, and thousands in the future. Please contact Keisha Williams, Clinical Research Coordinator 410-337-4500 for additional informationor email Keisha.Williams@espmgmt.com.
Current Clinical Trials
Opthea Clinical Trial
The National Retina is currently enrolling patients in the Opthea clinical trial for the treatment of Exudative (Wet) Macular Degeneration*.
Opthea is currently conducting two concurrent Phase 3 clinical trials with OPT-302, which are actively recruiting and enrolling treatment-naïve patients for the treatment of wet AMD.
The Phase 3 trials, referred to as ShORe and COAST, are double-masked, sham-controlled trials that enroll treatment-naïve patients and assess the efficacy and safety of 2.0 mg OPT-302 in combination with anti-VEGF-A therapy, compared to standard of care anti-VEGF-A monotherapy. In addition, to understand the durability of OPT-302 treatment effect with less frequent dosing, each trial will compare the clinical efficacy of OPT-302 administered in combination with the applicable VEGF-A inhibitor on an every 4-week and every 8-week dosing regimen.
The primary endpoint of both trials will be the mean change in visual acuity from baseline at week 52. Patients will continue to be dosed until week 96 to further assess long-term safety at week 100.
Opthea began patient recruitment into the Phase 3 trials, ShORe and COAST, in the first half of 2021.
Download the brochure below to find out about our latest clinical research study and how you can participate.
The 20170542 Study-A clinical research study for men and women with neovascular (wet) age-related macular degeneration.
Amgen 938 Phase iii
A randomized, double-masked, Phase 3 study of APB 938 efficacy and safety compared to Aflibercept (Eylea) in adults with Neovascular Age-Related Macular Degeneration
*Currently enrolling patients.
Regeneron 1934 – PHOTON
The aim of the PHOTON Study is to evaluate the safety and effectiveness of an investigational drug product for patients with Diabetic Macular Edema.
For further details please call our Clinical Research Coordinator, Keisha Williams, at The National Retina Institute at 410-337-4500 or email Keisha.Williams@espmgmt.com.
Upcoming Trials
NRI is in the process of enrolling in several new clinical trials. Details will follow as the enrollment process is completed.
Past Trials
Horizon RVO: “FVF3426g (HORIZON)
An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability Of Ranibizumab in Subjects with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) Who Have Completed The Treatment Phase Of A Genentech Sponsored Ranibizumab Study
RIDE-FVF4168g
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study of the efficacy and safety of ranibizumab injection in patients with clinically significant macular edema with center involvement (CSME-CI) secondary to diabetes mellitus (Type 1 or 2).
Marina-FVF2598g
An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study
Focus FVF2428g
This is an open-label multicenter extension study for participants who have completed one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), or FVF2598g (NCT0056823). Cohort 1 includes patients with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD).
Sailor- FVF3689g
A Phase IIIb, Multicenter Study to Evaluate the Safety and Tolerability of Ranibizumab in Naïve and Previously Treated Subjects with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
RAP
FVF3423s: Phase 1 Study of Intravitreal Lucentis for the Treatment of Stage 1 and 2 Retinal Angiomatous Proliferations
WIRB-Protocol-#20052536
Comparison of Intravitreal Versus Anterior Sub-Tenon’s Injection of Triamcinolone Acetonide for Refractory Diabetic Macular Edema, A Randomized Clinical Trial
WIRB-Protocol-#20051556
An Observational Case Series of Patients Who Underwent Surgery for Full-Thickness Macular Holes and Assessed Pre- and Post-Operatively With the Micro Perimeter (MP1)
CLEAR-IT1
A Phase I, Dose-Escalation, Safety, Tolerability, and Bioactivity Study of Intravitreal VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration
EOP1004H
A Phase II/III Randomized, Double Masked, Controlled, Dose-Ranging, Multi-Center Comparative Trial, in Parallel Groups, To Establish the Safety and Efficacy of EYE001 (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks For 54 Weeks, in Patients With Exudative Age-Related Macular Degeneration (AMD)
AMD-02-99
A Multicenter, Prospective, Randomized, Double-Masked Study Comparing the Safety and Efficacy of Membrane Differential Filtration to a Placebo Treatment in Patients with Non-Exudative Age-Related Macular Degeneration
VGFT-OD-0508
The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD. This is a double-masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period.
TG-MV-006
A Randomized, Placebo-Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion
AG3340-801
A Phase II, Randomized, Double-Masked, Placebo-Controlled Study of the Matrix Metalloproteinase Inhibitor AG3340 in Patients with Subfoveal Choroidal Neovascularization Associated with Age-Related Macular Degeneration
AMD-02-99
A Multicenter, Prospective, Randomized, Double-Masked Study Comparing the Safety and Efficacy of Membrane Differential Filtration to a Placebo Treatment in Patients with Non-Exudative Age-Related Macular Degeneration
B7A-MC-MBBK
Protein Kinase C Inhibitor ß – Diabetic Macular Edema Study
B7A-MC-MBBM
Protein Kinase C Inhibitor ß – Diabetic Retinopathy Study
PDTP-920101-OP004
Phase I/II SnET2 Treatment of Subfoveal Choroidal Neovascularization Associated with Age-Related Macular Degeneration
PDTP-920101-OP002
Phase I/II SnET2 Treatment of Subfoveal Choroidal Neovascularization
NAVILAS Laser Use in Retinal Tissue
Navilas laser is a cutting-edge technology, which allows for precise placement of laser sport to retinal tissue. During treatment, the computer system will constantly track the patient’s eye movement to direct laser spots more precisely than manual delivery.
Subvisible Micropulse (SVMP) Laser for Neovascular Age-Related Macular degeneration (AMD)
The goal of this study is to evaluate the beneficial effects of micropulse laser in the treatment of wet macular degeneration. Potential benefits for the patients include l fewer of injections, faster recovery, and better vision.
MicroPulse in Retinal Disease
NRI is on the cutting edge in conducting studies evaluating the role of micropulse laser in the treatment of a variety of retinal disorders. A Micropulse laser is a gentle laser that does not burn the retina. Instead, it will stimulate the retina to produce beneficial proteins. These proteins in turn will make retina healthier. Numerous studies have shown micropulse laser to be effective for the treatment of a variety of retinal conditions.
CLS1003-302 TOPAZ
A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in combination with an intravitreal Anti-VEGF agent in subjects with retinal vein occlusion.
ALLERGAN CEDAR-150998-005
Safety and efficacy of Abicipar Pegol (AGN–150998-005) in patients with neovascular age-related macular degeneration.
OCULAR PROTEOMICS- The Vitreous Proteome-20060001
NRI conducted the vitreous proteomics study for over 10 years. The goal of this study was to learn about protein components of the eye and to understand which proteins are associated with each retinal disorder.
GENENTECH (BOULEVARD)-BP29647
A multiple-center, multiple-dose, and regimen, randomized, active comparator-controlled, double-masked, parallel-group, 36-week study to investigate the safety, tolerability, pharmacokinetics, and efficacy of RO6867461 administered intravitreally in patients with choroidal neovascularization secondary to age-related macular degeneration.
