Clinical trials: Diabetic Macular Edema (DME)
Retinal Disease
Study to Gather Information on the Safety and Use of Aflibercept Injections Into the Eye for the Treatment of Eye Disorders in Mexican Routine Clinical Practice
The study aims to collect data on the safety and use of intravitreal aflibercept injections into the eye for the treatment of eye disorders that cause blurred vision or a blind spot due to abnormal or blocked blood vessels.
- Trial name
- MAIA (NCT04137120)
- Testing
- Aflibercept (BAY86-5321, Eylea)
- Where
- Mexico
- Volunteers
- 73 people
- Sponsor
- Bayer
Macular Edema
Efficacy and Safety of Three Different Aflibercept Regimens in Subjects With Diabetic Macular Edema (DME)
To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections…
- Trial name
- VIOLET (NCT02818998)
- Testing
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Where
- 64 sites in Austria, Canada and 12 more
- Volunteers
- 463 people
- Sponsor
- Bayer
Diabetic Macular Edema
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)
The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as…
- Trial name
- NCT07425522
- Testing
- RO7823653, Faricimab
- Where
- 12 sites in United States
- Volunteers
- 93 people
- Sponsor
- Genentech, Inc.
Diabetic Macular Edema
Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema (DME)
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement to be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®.
- Trial name
- DME (NCT03610646)
- Testing
- MYL-1701P, Eylea
- Where
- 73 sites in United States, Czechia and 7 more
- Volunteers
- 355 people
- Sponsor
- Mylan Pharmaceuticals Inc
Diabetic Macular Edema
The Study of Drug 601 in Patients With Diabetic Macular Edema (DME)
Observe the safety and tolerability of the single and multiple doses of 601 in DME patients; study the pharmacokinetic characteristics of single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple…
- Trial name
- NCT04151407
- Testing
- Drug 601
- Where
- 4 sites in China
- Volunteers
- 50 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Diabetic Macular Edema (DME)
Phase 3 Study of Intravitreal OLN324 in Adults With Diabetic Macular Edema (DME) (OLN324-CP-02)
This is a Phase 3 study of an investigational drug called OLN324, which is being developed by Ollin Biosciences as a treatment for patients with diabetic macular edema (DME).
- Trial name
- ATACAMA (NCT07841899)
- Testing
- OLN324, Aflibercept
- Volunteers
- 450 people
- Sponsor
- Ollin Biosciences, Inc.
Diabetic Macular Edema
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
- Trial name
- MIVI-II (NCT00412451)
- Testing
- ocriplasmin
- Where
- 15 sites in Belgium, Germany and 4 more
- Volunteers
- 51 people
- Sponsor
- ThromboGenics
Diabetes Mellitus, Diabetic Retinopathy
A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)
This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
- Trial name
- NCT03511898
- Testing
- THR-149 dose level 1, THR-149 dose level 2, THR-149 dose level 3
- Where
- 7 sites in United States
- Volunteers
- 12 people
- Sponsor
- ThromboGenics
Choroidal Neovascularization, Diabetic Retinopathy
PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)
This is a two-part study. The first part (Stratum I) is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be given to all patients who participate.
- Conditions
- Choroidal Neovascularization, Diabetic Retinopathy, Diabetic Macular Edema
- Trial name
- MATISSE (NCT01445899)
- Testing
- PF-04523655 (Stratum I), ranibizumab, PF-04523655 (Stratum II)
- Where
- 51 sites in United States, Belgium and 5 more
- Volunteers
- 258 people
- Sponsor
- Quark Pharmaceuticals
Visual Impairment, Neovascular Age-related Macular Degeneration (nAMD)
The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in Treating Visual Impairment Due to Neovascular Age-related Macular Degeneration or Diabetic Macula Edema
This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors.
- Conditions
- Visual Impairment, Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macula Edema (DME)
- Trial name
- NCT06075147
- Testing
- Aflibercept 8 mg (VEGF Trap-Eye, BAY86-5321)
- Where
- 18 sites in Australia, Canada and 16 more
- Volunteers
- 2,500 people
- Sponsor
- Bayer
Neovascular Age-related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Retinal Vein Occlusion (RVO)
DATA-INSIGHT is a Project That Looks at Health Data in Germany to Find Out How Many Patients Suffer From Eye Disease. The Project Also Explores New Ways to Collect and Use Publicly Available Healthcare Information.
The main goal of this study is to find out how common certain eye diseases are in Germany and how they have changed over time. The diseases being studied are: nAMD (neovascular age-related macular degeneration): a condition that…
- Trial name
- NCT07308639
- Testing
- anti-VEGF medication
- Where
- Germany
- Volunteers
- 50,000 people
- Sponsor
- Bayer
Diabetic Macular Edema (DME)
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
The purpose of this study is to learn about the effects of BGE-102 on change in vision in participants with center-involved diabetic macular edema (CI-DME).
- Trial name
- QUELL-DME (NCT07812090)
- Testing
- Oral BGE-102, Anti-VEGF
- Where
- 16 sites in United States
- Volunteers
- 180 people
- Sponsor
- BioAge Labs, Inc.
Diabetic Macular Edema (DME)
A First-in-human Trial of SZN-8141 in Diabetic Macular Edema
DUET (Cl-8141-1001) is a first-in-human clinical trial evaluating the safety, tolerability, pharmacokinetics (how the body processes the study drug), and preliminary biological activity of SZN-8141 in people with diabetic macular…
- Trial name
- DUET (NCT07817121)
- Testing
- SZN-8141 for Injection
- Volunteers
- 9 people
- Sponsor
- Surrozen Operating, Inc.
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
Evaluation of IBI302 Injection in nAMD or DME
The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.
- Trial name
- NCT05961007
- Testing
- Intravitreal injection of IBI302(dose 1), Intravitreal injection of IBI302(dose 2), Intravitreal injection of IBI302(dose 3)
- Where
- China
- Volunteers
- 234 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Diabetes Mellitus, Diabetic Retinopathy
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3.
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema
- Trial name
- KALAHARI (NCT04527107)
- Testing
- THR-149 dose level 1, THR-149 dose level 2, THR-149 dose level 3
- Where
- 78 sites in United States, Czechia and 6 more
- Volunteers
- 135 people
- Sponsor
- Oxurion
Diabetic Macular Edema (DME)
Phase 3 Study of Intravitreal OLN324 in Adults With Diabetic Macular Edema (DME) (OLN324-CP-03)
This is a Phase 3 study of an investigational drug called OLN324, which is being developed by Ollin Biosciences as a treatment for patients with diabetic macular edema (DME).
- Trial name
- GOBI (NCT07842016)
- Testing
- OLN324, Aflibercept
- Volunteers
- 450 people
- Sponsor
- Ollin Biosciences, Inc.
Diabetic Macular Edema (DME)
Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema
This study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18…
- Trial name
- CONGO (NCT04697758)
- Testing
- AXT107 0.1 mg, AXT107 0.25 mg, AXT107 0.5 mg
- Where
- 10 sites in United States
- Volunteers
- 6 people
- Sponsor
- AsclepiX Therapeutics, Inc.
Diabetic Macular Edema (DME), Age-Related Macular Degeneration (AMD)
Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections
This Phase 4, multicenter, randomized, double-masked clinical study evaluates the efficacy and safety of chloroprocaine hydrochloride ophthalmic gel 3% (IHEEZO) compared with routine anesthesia (topical proparacaine 0.5% combined…
- Conditions
- Diabetic Macular Edema (DME), Age-Related Macular Degeneration (AMD), Retinal Vein Occlusion, Diabetic Retinopathy (DR)
- Trial name
- Quell (NCT07456826)
- Testing
- Chloroprocaine Ophthalmic Gel 3% (IHEEZO), Proparacaine Hydrochloride Ophthalmic Solution 0.5%, Lidocaine Hydrochloride Injection 2%
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- Harrow Inc
Neovascular Age-related Macular Degeneration, Macular Oedema Secondary to RVO
A Trial to Evaluate the Safety and Usability of the SB15 PFS in Trial Participants With AMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema
This is an open label, multicenter, Phase II trial to evaluate the safety and usability of the pre-filled syringe (PFS) of SB15 (Aflibercept biosimilar).
- Conditions
- Neovascular Age-related Macular Degeneration, Macular Oedema Secondary to RVO, Diabetic Macular Oedema
- Trial name
- NCT07844343
- Testing
- SB15 PFS
- Where
- 3 sites in South Korea
- Volunteers
- 33 people
- Sponsor
- Samsung Bioepis Co., Ltd.
DME, Diabetic Macular Edema
Study of CU06-1004 in Patients With Daibetic Macular Edema
This phase 2b trial is a randomized, double-masked, parallel-group, multi-center study in approximately 156 patients with Diabetic Macular Edema to evaluate the efficacy and safety of CU06-1004 orally administered once daily for…
- Conditions
- DME, Diabetic Macular Edema, Diabetic Macular Edema (DME)
- Trial name
- NCT07459829
- Testing
- CU06-1004
- Volunteers
- 156 people
- Sponsor
- Curacle Co., Ltd.