Clinical trials: Stage 3 AMD
Neovascular Age-related Macular Degeneration (nAMD)
A Phase 3 Clinical Trial to Compare RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration
This clinical study is designed to demonstrate the equivalence of the two Investigational Products by comparing the efficacy, safety, tolerability and immunogenicity of RBS-001 and Eylea® in subjects with Neovascular age-related…
- Trial name
- NCT06470373
- Testing
- RBS-001 Solution for intravitreal injection, Eylea® Solution for intravitreal injection
- Where
- 7 sites in United States
- Volunteers
- 434 people
- Sponsor
- Rophibio, Inc.
Wet Macular Degeneration
A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
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…
- Trial name
- DAZZLE (NCT04049266)
- Testing
- KSI-301, Aflibercept
- Where
- 75 sites in United States, Czechia and 5 more
- Volunteers
- 559 people
- Sponsor
- Kodiak Sciences Inc
Stargardt Disease
A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease
Phase 2/3 Pivotal Confirmatory Clinical Trial is a randomized, outcome assessor-masked, multicenter study, that will enroll fifty-one (51) subjects.
- Trial name
- GARDian3 (NCT05956626)
- Testing
- OCU410ST
- Where
- 14 sites in United States
- Volunteers
- 51 people
- Sponsor
- Ocugen
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Background: The eyeGENE (Registered Trademark) program is a research resource for inherited eye conditions which includes genotypic and phenotypic data, imaging, and a corresponding biobank of DNA samples from people with a…
- Conditions
- Inherited Ophthalmic Diseases, Hypopigmentation Disorder, Corneal Dystrophy, Blue-cone Monochromacy
- Trial name
- NCT06491615
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- National Eye Institute (NEI)
Geographic Atrophy
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.
- Trial name
- PHOENIX (NCT05949593)
- Testing
- Tinlarebant
- Where
- 49 sites in United States, Australia and 6 more
- Volunteers
- 429 people
- Sponsor
- Belite Bio, Inc
Geographic Atrophy, Age-Related Macular Degeneration
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Age-related macular degeneration (AMD) is an eye disease which causes people to lose their vision over time. AMD damages the macula, which is in the middle of the retina - the light sensitive part at the back of the eye.
- Trial name
- NCT06970665
- Testing
- avacincaptad pegol
- Where
- 11 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Astellas Pharma Inc
Age Related Macular Degeneration
Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)
The purpose of this study is to compare the safety and effectiveness of three doses of intravitreal bevasiranib sodium as maintenance therapy for Age-Related Macular Degeneration following initiation of anti-VEGF therapy with…
- Trial name
- CARBON (NCT00557791)
- Testing
- Bevasiranib, ranibizumab
- Sponsor
- OPKO Health, Inc.
Wet Age-related Macular Degeneration
A Study to Compare JL14002 to Lucentis® in Subjects With Wet Age-related Macular Degeneration (wAMD)
This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy and safety of JL14002 compared to Lucentis® in subjects with wAMD.
- Trial name
- NCT07389577
- Testing
- JL14002 monoclonal antibody(Fixed dosing regimen), Ranibizumab(Fixed dosing regimen), JL14002 monoclonal antibody(PRN)
- Where
- China
- Volunteers
- 443 people
- Sponsor
- Jecho Biopharmaceuticals Co., Ltd.
Geographic Atrophy
A 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
This is a 24-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.
- Trial name
- NCT03525613
- Testing
- APL-2
- Where
- 112 sites in United States, Australia and 12 more
- Volunteers
- 637 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
Pompe Disease (Late-onset)
A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease
This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.
- Trial name
- PROPEL (NCT03729362)
- Testing
- Cipaglucosidase Alfa, Miglustat, Alglucosidase Alfa
- Where
- 73 sites in United States, Argentina and 22 more
- Volunteers
- 125 people
- Sponsor
- Amicus Therapeutics
Age-Related Macular Degeneration
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal…
- Trial name
- NCT01940900
- Testing
- E10030, ranibizumab
- Where
- 121 sites in United States, Argentina and 9 more
- Volunteers
- 627 people
- Sponsor
- Ophthotech Corporation
Macular Edema, Diabetic Mellitus
A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema
The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.
- Conditions
- Macular Edema, Diabetic Mellitus, Retinal Disease
- Trial name
- NCT01100307
- Testing
- pegaptanib sodium
- Where
- 43 sites in Japan
- Volunteers
- 243 people
- Sponsor
- Pfizer
Wet Age Related Macular Degeneration, wAMD
A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56
This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.
- Trial name
- wAMD (NCT06683742)
- Testing
- EYP-1901, Aflibercept (2.0 mg)
- Where
- 113 sites in United States, Brazil and 8 more
- Volunteers
- 400 people
- Sponsor
- EyePoint Pharmaceuticals, Inc.
Pompe Disease (Late-onset)
A Study to Assess the Long-term Safety and Efficacy of ATB200/AT2221 in Adult Subjects With Late-Onset Pompe Disease (LOPD)
This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.
- Trial name
- NCT04138277
- Testing
- AT2221, ATB200
- Where
- 60 sites in United States, Argentina and 21 more
- Volunteers
- 119 people
- Sponsor
- Amicus Therapeutics
Macular Degeneration
Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation at year 2.
- Trial name
- NCT02228304
- Testing
- NT-503-3 ECT implantation, Eylea® injected intravitreally administered every 8 weeks
- Where
- 38 sites in United States, Israel
- Volunteers
- 42 people
- Sponsor
- Neurotech Pharmaceuticals
Diabetic Macular Edema
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).
- Trial name
- KESTREL (NCT03481634)
- Testing
- Brolucizumab, Aflibercept
- Where
- 116 sites in United States, Argentina and 12 more
- Volunteers
- 566 people
- Sponsor
- Novartis Pharmaceuticals
Geographic Atrophy, Age-Related Macular Degeneration
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 23 visit on study…
- Trial name
- NCT05536297
- Testing
- avacincaptad pegol
- Where
- 117 sites in United States, Argentina and 15 more
- Volunteers
- 278 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Eye Diseases, Macular Degeneration, Wet
Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
The centre of the retina (macula) at the back of the eye contains cells that give us our central vision that we use for reading and recognising faces.
- Conditions
- Eye Diseases, Macular Degeneration, Wet, Sub-Macular Hemorrhage
- Trial name
- TIGER (NCT04663750)
- Testing
- Pars plana vitrectomy, Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until month 12, subretinal injection of recombinant TPA (Alteplase) up to a maximum of 25 micrograms in 0.2 mls
- Where
- 42 sites in Germany, Ireland and 5 more
- Volunteers
- 210 people
- Sponsor
- King's College Hospital NHS Trust
Wet Age-related Macular Degeneration
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants with Neovascular (Wet) Age-related Macular Degeneration (wAMD)
- Trial name
- DAYBREAK (NCT06556368)
- Testing
- Tarcocimab tedromer, Tabirafusp tedromer, Aflibercept
- Where
- 72 sites in United States, Puerto Rico
- Volunteers
- 675 people
- Sponsor
- Kodiak Sciences Inc
Late-onset Pompe Disease
BMN 701 Phase 3 in rhGAA Exposed Subjects With Late Onset Pompe Disease (INSPIRE Study)
Study 701-301 is a single-arm, open-label, switchover study in patients with late-onset Pompe disease who have been receiving treatment with recombinant human acid alpha-glucosidase (rhGAA) for 48 weeks or longer.
- Trial name
- NCT01924845
- Testing
- BMN 701
- Where
- 22 sites in United States, Belgium and 6 more
- Volunteers
- 24 people
- Sponsor
- BioMarin Pharmaceutical