Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema
NCT02348918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218
Last updated 2018-12-07
Summary
A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema
Conditions
Interventions
- DRUG
-
Luminate 1.0mg
- DRUG
-
Luminate 2.0mg
- DRUG
-
Luminate 3.0mg
- DRUG
- DRUG
-
Luminate 0.5mg
Sponsors & Collaborators
-
Trial Runners, LLC
collaborator OTHER - collaborator OTHER
-
Allegro Ophthalmics, LLC
lead INDUSTRY
Principal Investigators
-
Vicken Karageozian · Cheif Medical Officer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-10-13
- Primary Completion
- 2017-05-16
- Completion
- 2017-06-13
Countries
- United States
Study Locations
More Related Trials
-
A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
NCT01089517 ·Status: COMPLETED ·Phase: PHASE2
-
Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema
NCT02734407 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab
NCT04597918 ·Status: COMPLETED ·Phase: PHASE2
-
Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula
NCT00040313 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
NCT03481634 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)
NCT05698329 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema
NCT05151731 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration (AMD)
NCT01301443 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate Vamikibart in Participants With Uveitic Macular Edema
NCT05642312 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema
NCT06850922 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Pegaptanib Therapy in Non-Infectious Uveitic Cystoid Macular Edema
NCT00790803 ·Status: COMPLETED ·Phase: NA
-
Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 With or Without Lucentis™ in Patients With Wet AMD
NCT02543229 ·Status: COMPLETED ·Phase: PHASE1
-
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
NCT05697809 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy
NCT01940887 ·Status: TERMINATED ·Phase: PHASE3
-
An Open-Label Investigator Sponsored Trial to Investigate the Safety, Tolerability and Development of Subfoveal Fibrosis By Intravitreal Administration of Altering Regimens of Fovista and Anti-VEGF Therapy in Subjects With Neovascular Age-Related Macular Degeneration
NCT02591914 ·Status: COMPLETED ·Phase: PHASE1
-
The Study of CU06-1004 in Patients With Diabetic Macular Edema (DME)
NCT05573100 ·Status: COMPLETED ·Phase: PHASE2
-
Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD
NCT00527423 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II/III Study of Anti-VEGF in Neovascular AMD
NCT00021736 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration
NCT01749891 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration
NCT02848313 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)
NCT01997164 ·Status: COMPLETED ·Phase: PHASE1
-
Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers
NCT05729594 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
NCT06491914 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD
NCT04331730 ·Status: COMPLETED ·Phase: PHASE2
-
A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56
NCT06668064 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3