Clinical Trials

Current Trials

NHOR – A Natural History Observation and Registry Study of Macular Telangiectasia Type 2: The MacTel Study-Conducted at FS-one visit only with annual phone calls. MacTel confirmed by Reading Center.

DRCR AF– A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening – conducted at all offices except Pine Heights and Columbia – screening, randomization, three month, 6mths and every six months for 4 years. Eligibility determined by Reading Center and PCP approval based on labs taken during screening. Randomization – Fenofibrate vs placebo

DRCR AJ – Vitreous Proteomics in Eyes with macular holes-recruiting vitreous floaters – conducted at all offices except Pine Heights and Columbia. One visit for enrollment and then sample taken during surgery – only looking for males with macular holes or male/female with vitreous floaters

DRCR AM_ Randomized Trial Comparing Immediate versus Deferred Surgery for Symptomatic Epiretinal Membranes – conducted at all offices except Pine Heights and Columbia. No Reading Center approval. If assigned to surgery it must take place within one month of enrollment. With worsening of symptoms surgery can be performed in the deferred surgery group after meeting certain criteria. Follow-up one month post vitrectomy in surgery group, otherwise 3, 6, 12, 18, 24 and 36 months.

Opthea – ShORe – A Phase 3, Multicentre, 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). Conducted at FS only. Duration of study 2 years-monthly visits

Alexion ALXN2040 – Proof of concept and dose-finding study of Danicopan in patients with geographic atrophy secondary to AMD.

Notal C2022.001 – Evaluation of Repeated, In-Clinic, Self-Imaging by DME Patients Using the Notal Vision Home OCT

OcuTerra Therapeutics, Inc – OTT 166-201 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)

Curacle Co.,Ltd – CU06-RE-P2A-01 – A Randomized, Open-label, Parallel-group, Multi-center Phase 2a Study to Evaluate the Efficacy and Safety of CU06-1004 for 12 Weeks in Patients with Diabetic Macular Edema (DME)

Past Trials

Alexion Pharmaceuticals

Description: A Phase 2, Double-Masked, Placebo-Controlled, Dose Range Finding Study of Danicopan (ALXN2040) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Alimera (New Day)

Description: A Randomized, Masked, Controlled Study of Intravitreal Iluvien Implant as Baseline Therapy in Patients with Diabetic Macular Edema (DME)

Apellis-APL2-GA-305

Description: 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

ARIS – AMD Ryan Initiative Study

Description: To assess rate of change in drusen volume and progression rates to large drusen, and associate these morphologic changes with psychophysical changes, including visual acuity and dark adaptation.

Catalina NGM-621-GA-201

Description: A Phase 2, Multicenter, Randomized, Double-Masked, Sham-Controlled Stuyd of the Safety and Efficacy of Intravitreal Injections of NGM621 in Subjects with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Clover Therapeutics (PROGRESSION)

Description: A decentralized epidemiological study of the progression of Age-Related Macular Degeneration

Boehringer Ingelheim

Description: A First-in Human Trial to study safety and tolerability of single rising intravitreal doses (open label, non-randomized, uncontrolled) and in addition the early biological response of multiple intravitreal doses (single-masked, randomized, sham-controlled) of BI765128 in panretinal photocoagulation (PRP) treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischemia.

DRCR Retina Network

Diabetic Retinopathy Clinical Research Network

Protocol W: Treatment for patients with severe NPDR, determined by Reading Center.

Description: Patient are treated with Eylea versus sham (observation) to determine if early treatment will slow the progression to PDR. Vision 20/25 or better. 4 year study

Protocol AF

Description: A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening

Kodiak Sciences

Description: A Prospective, Randomized, Double-masked, Sham-controlled, Multi-center, Two-Arm, Phase 3 Study to evaluate the effficacy and safety of intravitreal KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy

MacTel NHOR

Description: A Natural History Observation and Registry Study of Macular Telangiectasia Type 2

Notal C2021.001

Description: Home OCT Visualization Agreement Study

Novartis CDDO001B2001

Description: Feasibility of Visual Acuity Assessments Using FocalView at Home and in the Clinic, including Comparison with E-ETDRS Assessment in the Clinic, in Subjects with Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema

Opthea ShORe

Description: A Phase 3, Multicentre, 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)

AREDS2, Age-Related Eye Disease Study

Randomized Trial of Lutein, Zeaxanthin, and Long-Chain Omega-3 Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration

Age-related Eye Disease Study (AREDS2)

10-Year Follow-on Study

Description: Provide additional data regarding the incidence of advanced AMD, cataract surgery and lung cancer on approximately 1,200 AREDS2 study participants

Age-Related Eye Disease Study (AREDS2)

Foreseehome: Home Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the Foreseehome Device

ALCON RTH258-C001

A Two-Year, Randomized, Double-Masked, Multicenter, Three-Arm Study Comparing the Efficacy and Safety of RTH258 versus Aflibercept in Subjects with Neovascular Age-related Macular Degeneration

Description: To demonstrate that RTH258 is not inferior to aflibercept with respect to the change in BCVA from baseline in patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration. Treatment arms: RTH258 3 mg, RTH258 6 mg and Aflibercept.

ALLERGAN CEDAR

150998-005 Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-Related Macular Degeneration

Description: To assess the safety and efficacy of abicipar compared with ranibizumab in patients with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration. Treatment arms: 2mg abicipar 8 weeks, 2mg abicipar 12 weeks and ranibizumab.

Apellis Derby

A Phase III, Multi-center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Description: To determine if intravitreally injected APL-2 reduces the progression of GA compared to sham-injections in patients with GA secondary to AMD.

Apellis FILLY-POT

Description: Patients with Geographic Atrophy determined by Reading Center. Randomized to one of 4 arms. Study drug Monthly; Study drug EOM; Sham Monthly; Sham EOM. 12 month study.

APGS – AMD Phenotype and Genotype Study
ALLERGAN CEDAR

150998-005 Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-Related Macular Degeneration

CATT

Comparison of Age-Related Macular Degeneration Treatment Trials

DRCR Retina Network

Diabetic Retinopathy Clinical Research Network

Protocol S: Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab with Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

Description: To determine if visual acuity outcomes at 2 years in eyes with PDR that receive anti-VEGF therapy with deferred PRP are non-inferior to those in eyes that received standard prompt PRP therapy.

Protocol T: A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema

Description: To compare the efficacy and safety of intravitreal aflibercept, intravitreal bevacizumab and intravitreal ranibizumab when given to treat center-involved DME in eyes.

Protocol U: Short-term Evaluation of Combination Corticosteroid + Anti-VEGF Treatment for Persistent Central-Involved Diabetic Macular Edema Following Anti-VEGF Therapy

Description: To assess the short-term effects of combination steroid + anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with that of continued anti-VEGF done in eyes with persistent center-involved DME and decreased visual acuity despite previous anti-VEGF treatment.

Protocol V: Treatment for Central-Involved Diabetic Macular Edema in Eyes with Very Good Visual Acuity

Description: To compare the safety and efficacy of prompt focal/grid photocoagulation + deferred intravitreal anti-VEGF, observation + deferred intravitreal anti-VEGF, and prompt intravitreal anti-VEGF in eyes with central-involved DME and good visual acuity 20/25 or better.

Protocol AA: Peripheral Diabetic Retinopathy Lesions on Ultrawide-field Fundus Images and Risk of DR Worsening over Time

Description: To assess whether evaluation of the retinal far periphery on ultrawide-field images improves the ability to assess DR and predict rates of DR worsening over time as compared with evaluation only of the area within the 7 standard ETDRS fields.

Protocol AB: Intravitreous Anti-VEGF vs. Prompt Vitrectomy for Vitreous Hemorrhage from Proliferative Diabetic Retinopathy

Description: To evaluate and compare visual acuity outcomes over the course of the study of a prompt vitrectomy + PRP regimen and an intravitreous aflibercept regimen in eyes with VH from PDR for which intervention is deemed necessary

Protocol AD: Diabetic Retinopathy Outcomes in a Randomized Trial of Pemafibrate vs. Placebo

Description: To assess whether treatment with pemafibrate (0.2 mg orally BID) compared with placebo reduces the hazard rate of diabetic retinopathy worsening in adults with type 2 diabetes and diabetic retinopathy without neovascularization in at least one eye who are participating in the parent PROMINENT trial.

EOP 1023

Description: A Phase IV, open label, multi-center trial of maintenance intravitreal injections of Macugen (pegaptanib sodium) given every 6 weeks for 48 weeks in subjects with subfoveal neovascular Age-Related Macular Degeneration (AMD) initially treated with modality resulting in maculopathy improvement.

GENENTECH (BOULEVARD)

Description: DME determined by Reading Center. Randomized to one of 3 arms. Lucentis q4weeks; Study drug (1.5mg) q4weeks; Study drug (6mg) q4weeks. Vision 20/40-20/320. 7 month study

GENENTECH GX29455

A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy

Description: The GX29455 Phase II is a controlled study of the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks or every 4 weeks for 24 weeks to CFI profile biomarker-positive patients with GA secondary to age-related macular degeneration (AMD). Treatment arms: lampalizumab every 2 weeks, lampalizumab every 4 weeks and sham injection.

Home Vision Monitoring in AREDS2 for progression to Neovascular AMD Using the ForeseeHome Device

Description: To assess home vision monitoring using the ForeseeHome Device vs. Amsler grid in patients participating in AREDS2

iDEAL Study

A Randomized Multi-center, Phase 2 Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCO-007 as Monotherapy or in Combination with Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic macular edema with Involvement of the Foveal Center

MacTel NTMT

Description: A Phase 3 Multi-center, Randomized, Sham-Controlled Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2

MERCK ALZHEIMER STUDY

Novartis SPP100A2244 Study

A randomized, double-masked, placebo-controlled, add-on study to assess the efficacy of oral aliskiren 300mg once daily for diabetic macular edema

Notal ALOFT

Description: Analysis of the Long-term visual Outcomes of ForeseeHome Remte Telemonitoring

Notal Home OCT C2020.005

Description: Evaluation of Repeated, In-clinic, Self-imaging by NV-AMD Patients Using the Notal Vision Home OCTNovartis

A Multi-center, randomized, sham-controlled, repeat-dose study to assess the safety-tolerability, serum pharmokinetics, and efficacy of intravitreal LFG316 in patients with neovascular age-related macular degeneration.

Ohr 002

Phase 2 study of the efficacy and safety of Squalamine Lactate Ophthalmic Solution 0.2% twice daily in subjects with neovascular age-related macular degeneration

Ohr 003

Topical Squalamine In The Treatment Of Retinal Neovascularization From Proliferative Diabetic Retinopathy.

OHR

Description: Randomized to study drug (drops) or placebo. Patients will receive Lucentis Monthly for 1 year then PRN in year 2. Will use drops BID throughout the study. Vision 20/40-20/320. 2 year study

OHR 1501

Description: Phase 2 study of safety, functional and anatomical effect of Squalamine Lactate Ophthalmic Solution 0.2% administered twice daily in subjects with neovascular age-related macular degeneration

ORBIT

Ocriplasmin Research to Better Inform Treatment. (Not enrolling)

PEACHTREE

Uveitis study. Patients with non-infectious uveitis and macular edema. Randomized to triamcinolone vs sham suprachoroidal injections at Day 0 and Week 12. Vision 20/40-20/800. 6 month study

Post Treatment Foresee Home

Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular AMD

POSURDEX

A 6-Month, Single-Masked, Multicenter, Randomized, Controlled Study to Assess the Safety and Efficacy of 700ug Dexamethasone Posterior Segment Delivery System Applicator System as Adjunctive Therapy to Lucentis Alone in the Treatment of Patients with Choroidal Neovascularization Secondary to Age-Related Macular Degeneration.

REGENERON

Description: Study drug (2 different doses) versus Eylea. Patients receive 3 doses then re-randomized based upon findings to possible different arm. Vision 20/40-20/320. 32 week study.

SCORE2

Standard Care vs. Corticosteroid for Retinal Vein Occlusion 2 (Not enrolling)

Description: A randomized trial designed to test whether bevacizumab is non-inferior to aflibercept for the treatment of macular edema due to central retinal vein occlusion (CRVO). Treatment arms: intravitreal aflibercept(2mg) every 4 weeks or intravitreal bevacizumab (1.25mg) every 4 weeks.

SIRIUS

Allergan SIRIUS Study 211745-001

VERTACLE

Description: Multi-Center Randomized, Phase II/III Clinical Trial to Study the Effects of Preservative Free Triamcinolone Acetonide as an Adjunct to Photodynamic Therapy in Participants with Neovascular Age-Related Macular Degeneration

Xcovery

A Phase 1/2 Open-label, Dose Escalation Clinical Trial to Evaluate the Safety and Preliminary Biologic Activity/Efficacy of the VEGFR/PDGFR Inhibitor X-82 Administered Per Os in Subjects with Neovascular Age-related Macular Degeneration

XCOVERY 201

A Randomized, Double-Masked, Placebo-Controlled, Dose-Finding, Non-Inferiority Study of X-82 plus prn Eylea compared to prn Eylea monotherapy in neovascular AMD

Description: To evaluate the safety and efficacy of X-82 at three doses versus placebo in combination with intravitreal injection of Eylea prn for patients with wet age-related macular degeneration (AMD). Treatment arms: X-82 50mg, 100mg, or 200 mg plus Eylea prn versus placebo plus Eylea prn.

YD312-01-P2 (YD Global Life Science Company)

Multi-center, Randomized, Double-Blind, Dose-Finding, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of YD312 Tablet in Patients with Diabetic Macular Edema

Description: To evaluate the efficacy of YD312 to improve visual acuity in patients with diabetic macular edema (DME) compared to placebo and determine optimal dose of phase 2b study