Research

Tennessee Retina is an active participant in many national research trials. The efforts of our physicians and patients have led to the approval of many treatments now considered to be the standard of care, and our continuing involvement in clinical research offers access to new and potentially superior treatments to patients with sight-threatening conditions. Participating in a clinical trial could bring new hope for patients afflicted with different retinal diseases. Future generations may benefit from the volunteers' choice to further medical research. 

As with all patients, our clinical trial patients are very important to us, and we provide them with exceptional care and attention. Please contact your current eyecare provider to see if you may qualify for one of our studies or contact one of our Clinical Trial staff members with any questions at (615) 983-6000.

Diabetes in the Eyes

OcuTerra/Dream (Enrolling)
NCT05409235 Clinical Trials.gov

This randomized, double-masked, vehicle controlled, phase 2 study will evaluate the safety and efficacy of OTT166 ophthalmic solution in participants with diabetic retinopathy and select an optimum dosing regimen for Phase 3 pivotal trials. Approximately 210 participants diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) and who are treatment naïve (ie, no prior anti-vascular endothelial growth factor [anti-VEGF] or laser [focal, grid, pan-retinal photocoagulation (PRP)] administered) and participants who do not have center-involved diabetic macular edema (CI-DME) will be randomized into the following groups: OTT166 Cohort 1, OTT166 Cohort 2, Vehicle control Cohort 1, Vehicle control Cohort 2.

KALAHARI (Enrolling)

NCT04527107  Clinical Trials.gov

Part A of the study is conducted to select the THR-149 dose level.

Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

GLEAM (Active, Not Enrolling)
NCT04611152 Clinical Trials.gov

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with treatment-naïve DME.The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2.

INFINITY (Active, Not Enrolling)

NCT04418427 Clinical Trials.gov

A Phase 2, Multi-Center, Randomized, Double-Masked*, Active Controlled Study of ADVM-022 (AAV.7m8-aflibercept) in Subjects with Diabetic Macular Edema [INFINITY]

*sponsor unmasked for enhanced safety monitoring as of May 2021

INTEGRAL (Enrolling Soon)

NCT05063734 Clinical Trials.gov

This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).

KODAIK/GLOW (Active, Not Enrolling)

NCT05066230 Clinical Trials.gov

This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

PAGODA (Active, Not Enrolling)

NCT04108156  Clinical Trials.gov
This study will evaluate the efficacy, safety, and pharmacokinetics of the Port Delivery System with Ranibizumab (PDS) in Participants with Diabetic Macular Edema (DME) when treated every 24 weeks (Q24W) compared with intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W).

PAVILION (Active, Not Enrolling) 

NCT04503551 Clinical Trials.gov

Study GR41675 is a Multicenter, Randomized Study in Participants with Diabetic Retinopathy (DR) Without Center-Involved Diabetic Macular Edema (CI-DME) to Evaluate the Efficacy, Safety of the Port Delivery System with Ranibizumab (PDS) Relative to the Comparator Arm

PHOTON (Active, Not Enrolling)

NCT04429503 Clinical Trials.gov

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.

The secondary objectives of the study are as follows:
To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response
To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

RHONE-X: GR41987 (Active, Not Enrolling)

NCT04432831  Clinical Trials.gov
This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.


Age-Related Macular Degeration (AMD)
 

AFFAMED/CONQUER (Enrolling)

NCT05345769 Clinical Trials.gov

The Part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD. Subjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (MTD) or the maximally administered dose (MAD) has been reached.The Part 2 of study is a multicenter, randomized, double-masked, multiple- dose, parallel study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD.

GOLDEN  (Enrolling)

NCT03815825  Clinical Trials.gov

The purpose of the study is to evaluate the effect of IONIS-FB-LRx on the rate of change of the area of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) measured by fundus autofluorescence (FAF).

GR42163  (Enrolling)

NCT04615325  Clinical Trials.gov

This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single Intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age related macular degeneration (AMD). The participants will receive ITV injections of RO7303359 in the single ascending dose stage and maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 will be administered in the expansion stage.

LUNA (Enrolling)

NCT05536973  Clinical_Trials.Gov

Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-12 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.

ShORe (Enrolling)

NCT04757610 Clinical Trials.gov

A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

ASTELLAS (Active, Not Enrolling)

NCT03178149  Clinical Trials.gov

A Staged Study Incorporating a Phase 1b, Multicenter, Unmasked, Dose Escalation Evaluation of Safety and Tolerability and a Phase 2, Multicenter, Unmasked, Randomized, Parallel Group, Controlled, Proof of Concept Investigation of Efficacy and Safety of ASP7317 for Atrophy Secondary to Age-related Macular Degeneration

AVONELLE-X  (Active, Not Enrolling)

NCT04777201 Clinical Trials.gov

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval to participants with neovascular age-related macular degeneration who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this study will be enrolled upon completion of the end-of-study visit in the parent study.

BELVEDERE (Active, Not Enrolling)

NCT04853251 Clinical Trials.gov

Study ML43000 is a Phase IIIb/IV multicenter, open-label (visual assessor-masked) study designed to assess the efficacy and safety of PDS 100 mg/mL Q24W in patients with nAMD who have been previously treated with anti-VEGF agents other than ranibizumab. Approximately 200 patients will be enrolled at approximately 40 sites.

BURGUNDY (Active, Not Enrolling)

NCT04567303 Clinical Trials.gov

This is a first in-human study to investigate the safety and tolerability of RO7250284 administered through intravitreal (IVT) injections and via the Port Delivery System in participants with neovascular age-related macular degeneration (nAMD)

CATALINA (Active, Not Enrolling)

NCT04465955   Clinical Trials.gov

This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.

DAYLIGHT  (Active, Not Enrolling)

NCT04964089 Clinical Trials.gov

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve neovascular (wet) age-related macular degeneration (wAMD)

The primary endpoint will be assessed at Week 40; additional secondary endpoints for efficacy will be assessed by visit over time

DAZZLE/KODIAK  (Active, Not Enrolling)

NCT04049266  Clinical Trials.gov

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).

DERBY (Active, Not Enrolling)

NCT03525600  Clinical Trials.gov

This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

GALE  (Active, Not Enrolling)

NCT04770545 Clinical Trials.gov

This is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who participated in Study APL2-103 (NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600).

GALLEGO (Inactive)

NCT03972709 Clinical Trials.gov

A Phase II, multicenter, randomized, single-masked, sham injection-controlled study of the safety, tolerability, and evidence of activity of intravitreal injection of RO7171009 in patients with Geographic Atrophy secondary to age-related macular degeneration

GALLegOLE  (Active, Not Enrolling) 

NCT04607148  Clinical Trials.gov

The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of FHTR2163 administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).

OAKS (Active, Not Enrolling)

NCT03525613  Clinical Trials.gov

This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

OPTIC (Adverum) (Active, Not Enrolling)

NCT03748784  Clinical Trials.gov

An Open Label Phase 1 Study of ADVM-022 (AAV.7m8-aflibercept) in Neovascular (Wet) Age-Related Macular Degeneration

PORTAL - LADDER EXT GR40549 (Active, Not Enrolling)

NCT03683251  Clinical Trials.gov

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

RG-314-0101/AAVIATE (Not Enrolling)

(Two-Part screening): Serum Anti-AAV8 Neutralizing Antibody Assessment Study of Patients with Neovascular Age-related Macular Degeneration or Diabetic Retinopathy

RGX-314-2102: (A Phase 2, Randomized, Dose-escalation, Ranibizumab-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered via One or Two Suprachoroidal Space (SCS) Injections in Participants with Neovascular Age-Related Macular Degeneration (nAMD) (AAVIATE)

SPIAM  (Not Enrolling)

NCT03891875 Clinical Trials.gov

A Phase 2, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Subcutaneous Elamipretide Solution in Subjects with Age-Related Macular Degeneration with Geographic Atrophy

TENAYA (Not Enrolling)

NCT03823287 Clinical Trials.gov

A Phase III, multicenter, randomized, single-masked, active comparator controlled study to evaluate RO6867461 in patients with Neovascular Age-Related Macular Degeneration.

Vein Occlusion

BALATON  (Active, Not Enrolling)

NCT04740905  Clinical Trials.gov

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

BEACON  (Active, Not Enrolling)

NCT04592419  Clinical Trials.gov

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve macular edema secondary to RVO (either branch and central type).

The primary endpoint will be assessed at Week 24; additional secondary endpoints for efficacy will be assessed at Week 24 and Week 48.

This includes an optional open-label, two-arm, double-masked Extension Phase in which participants completing the primary BEACON study are eligible to participate. All participants who enroll into the Extension Phase will be treated with KSI-301 5 mg. The Extension Phase will have the final study assessment at Week 72 for efficacy endpoints and a final safety follow-up at Week 76.

COMINO  (Active, Not Enrolling)

NCT04740931  Clinical Trials.gov

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).

Melanoma

AURA (Enrolling)

NCT04417530  Clinical Trials.gov

The primary objective is to assess safety and efficacy of AU-011 via suprachoroidal injection to treat primary indeterminate lesions and small choroidal melanoma.

Uveitis 

ADVISE  (Enrolling)

NCT03828019  Clinical Trials.gov

Non-infectious intermediate, posterior, and panuveitides are chronic, potentially-blinding diseases. Vision-threatening cases require long-term therapy with oral corticosteroids and immunosuppression. Based upon preliminary data, adalimumab, a fully-human, anti-TNF-α monoclonal antibody, now US FDA-approved for uveitis treatment, may be a superior corticosteroid-sparing agent than conventional immunosuppressive drugs. The ADVISE Trial is multicenter randomized, parallel-treatment, comparative effectiveness trial comparing adalimumab to conventional (small molecule) immunosuppression for corticosteroid spring in the treatment of non-infectious, intermediate, posterior, and panuveitides.

Notal

(Internal Study)

The Notal study is evaluating the patient's ability to use the Notal OCT Analyzer (NOA) themselves without the assistance of a technician. The NOA scans the macula to pick up any changes in Subretinal Fluid the patient may have had in between visits. The hope is this study will show that patients would be able to perform the scans on the NOA on themselves in their home in the future.