Diabetes in the Eyes
NCT05919693
Treatment Naive DME
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.
In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.
In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.
NCT06491914
This study is researching an experimental drug called aflibercept 8 mg, referred to as "study drug". The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications.
The aim of the study is to see how safe and effective aflibercept 8 mg injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.
A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
NCT04611152
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.
Ph1b IVT for DME - Teatment naive OR previously treated (12 week wash out for anti-VEGF, 16 for HD Eylea and Vabysmo, 24 week for Ozurdex)
- Transportation is provided; Stipend $100, FE TX NOT COVERED /REIMBURSED BY SPONSOR
- Age great than or equal to 40
- SE VA = 20/40 - 20/320; FE VA greater than or equal to HM
- A1C greater than or equal to 12
- CST greater than or equal to 325
- Center involved DME diagnosed greater than or equal to 18 months prior to the screening
NCT04108156
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).
NCT04503551
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
NCT04429503
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 afliberceptNCT06099184
Previously Treated DME
A prospective, randomized, single-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to aflibercept
A Phase 2, Multicenter, Prospective, Randomized, Double-Masked, Parallel Study of EYP-1901, a Tyrosine Kinase Inhibitor (TKI), Compared to Aflibercept in Subjects With Diabetic Macular Edema (DME)
Age-Related Macular Degeration (AMD)
NCT05919693
Treatment Naive nAMD & Previously Treated nAMD
EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.
In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.
In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.
NCT05345769
CURRENTLY ON HOLD
Treatment Naive Wet AMD Studies
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.
NCT04757610
Treatment Naive Wet AMD Studies
A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
NCT05839041
Part 1 of the trial will be a multi-center, open label safety and dose escalation study with a potential enrollment of 30 participants having geographic atrophy (GA) secondary to macular degeneration. They will receive a single intravitreal injection of study drug (AVD-104) and will be followed for 3 months for safety observation. They will have both aqueous humor and peripheral blood drawn for pharmacokinetic and pharmacodynamic evaluations.
Part 2 will be a multi-center, double masked, randomized trial to evaluate the treatment effect of AVD-104 on participants with geographic atrophy secondary to macular degeneration. Participants will be randomized to high dose AVD-104, low dose AVD-104, or active comparator (avacincaptad). The primary endpoint will be the difference in the rate of growth of the GA area as measured by fundus autofluorescence.
NCT06223958
Treatment Naive Wet AMD Studies
Brief Summary
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (axitinib implant) in Subjects with Neovascular Age-Related Macular DegenerationOfficial Title
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 (nAMD)
Vein Occlusion
NCT04740905
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).
Uveitis
NCT05266430
This study will assess the efficacy and safety of RO7200220 in participants with uveitic macular edema.
NCT05642325
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema