Research

 

Clinical Research Trials

Retinal diseases are a leading cause of vision loss and blindness, affecting millions of people worldwide. Clinical trials are vital to the development of new treatments and therapies for these conditions, and there are many ongoing trials testing promising new approaches.

Star Retina is proud to take part in clinical research trials for many common retinal conditions. Below are trials for which we are currently enrolling new patients and those that have been completed.

Open Trials

Sponsor: REGENXBIO Inc.- ALTITUDE A Phase 2, Randomized, Dose-escalation, Observation-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered via a Single Suprachoroidal Space (SCS) Injection in Participants with Diabetic Retinopathy (DR) Without Center Involved-Diabetic Macular Edema.

KODIAK GLOW 2 (KS301P108) A Prospective, Randomized, Double-masked, Sham-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants with Diabetic Retinopathy (DR).
Sponsor: Oculis Sarl Operations- DX221 A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema.

Diamond trial, a drop used to treat Diabetic Macular Edema
Sponsor: RegenexBio ATMOSPHERE a randomized partially masked controlled clinical study to evaluate the efficacy and safety of RGX-314 Gene Therapy in participants with nAMD. Lucentis

Sponsor: RegenxBio ASCENT a randomized partially masked controlled clinical study to evaluate the efficacy and safety of RGX-314 Gene Therapy in participants with nAMD. Eyela

Sponsor: AbbVie Inc.- RGX-314-5101 A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314 Following Subretinal Administration in Participants with Neovascular Age-related Macular Degeneration and Fellow Eye Treatment Substudy.

SOL-1(OTX-TKI-2023-AM-301) A Phase 3, Multicenter, Double-Masked, Randomized, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age-Related Macular Degeneration.

SOL-R (OTX-TKI-2023-AMD-303) A Phase 3, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age-Related Macular Degeneration.

EyePoint (EYP-1901-302) A Phase 3, Multicenter, Prospective, Randomized, Double-Masked, Parallel-Group Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects with Wet AMD.

KODIAK DAYBREAK (KS301P109): A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Three-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer and Tabirafusp Tedromer Compared with Intravitreal Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD).
Geographic Atrophy Sponsor: ORA Cognition Therapeutics (PILL STUDY) A Randomized, Double-Masked, Placebo-controlled, Parallel group, Phrase 2 Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants with Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).

Sponsor: i-Lumen Scientific, Inc.- i-SIGHT Microcurrent stimulation therapy for nonexudative age-related macular degeneration: a multicenter, randomized, sham-controlled, feasibility device trial.

SIENNA (R3918-AMD-2326): A multicenter, randomized, double-masked, placebo-controlled phase 3 study of the efficacy, safety, and tolerability of subcutaneously administered pozelimab in combination with cemdisiran or cemdisiran alone in participants with geographic atrophy secondary to age-related macular degeneration.

Closed Trials

Sponsor: KODIAK GLEAM 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)

ETA: CLOSED

Sponsor: KODIAK GLOW A Prospective, Randomized, Double-masked, Active Comparatorcontrolled, 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)

ETA: CLOSED

Sponsor: ORA ANX007-GA-0 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) Geographic Atrophy (GA)

ETA: CLOSED

Sponsor: KODIAK Daylight 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) (DAYLIGHT)

ETA: CLOSED

Sponsor: OcuTerra-OTT 166-201 DREAM OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)

ETA: CLOSED

Sponsor: Opthea OPT-302-1005 COAST Eyelea OPT-302-1005-COAST A Phase 3, Multicentre, Double-masked, Randomized Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)

ETA: CLOSED

VGFTe-HD-RVO-2335: A Phase 3 randomized, double-masked, active-controlled study of the efficacy and safety of 8 mg Aflibercept in participants with Macular Edema following Retinal Vein Occlusions.

ETA: CLOSED

For referring doctors or patients who wish to learn more about our research protocols or activities, please continue reading below or contact our office at 817-378-4777

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