Clinical trials: Diabetic Macular Edema
Diabetic Macular Edema
Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment…
- Trial name
- RETAIN (NCT01171976)
- Testing
- Ranibizumab
- Where
- 68 sites in Belgium, Czechia and 11 more
- Volunteers
- 373 people
- Sponsor
- Novartis Pharmaceuticals
Diabetic Retinopathy (DR), Age-related Macular Degeneration (AMD)
Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders for Alzheimer's Disease Prevention
The study will explore the impact of photobiomodulation (PBM), pulsating at frequencies of red (660nm) and near-infrared (810nm)(NIR), concurrent with a ketogenic dietary protocol (serum ketones @ .5 - 2.0 mmol/L) to mediate…
- Conditions
- Diabetic Retinopathy (DR), Age-related Macular Degeneration (AMD), Mid-peripheral Drusen Formation, Diabetic Macular Edema (DME)
- Trial name
- NCT03859245
- Testing
- Photobiomodulation, Ketogenic diet
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bristlecone Health, Inc.
Macular Edema
A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
The Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator is used to deliver an implant with medicine to the eye. AbbVie is updating the DEX PS DDS Applicator.
- Trial name
- NCT04976777
- Testing
- Updated DEX PS DDS Applicator, Approved DEX PS DDS Applicator, Dexamethasone
- Where
- 7 sites in United States
- Volunteers
- 54 people
- Sponsor
- AbbVie
Diabetic Macular Edema
A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants…
- Trial name
- NCT03397264
- Testing
- Aflibercept, OPT-302
- Where
- 53 sites in United States, Australia and 2 more
- Volunteers
- 153 people
- Sponsor
- Opthea Limited
Diabetic Macular Edema
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema With Center Involvement
This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.
- Trial name
- RESOLVE (NCT00284050)
- Testing
- Ranibizumab 0.3 mg, Ranibizumab 0.5 mg
- Where
- Switzerland
- Volunteers
- 151 people
- Sponsor
- Novartis
Diabetic Macular Edema (DME)
Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema
A multicenter, randomized, double-blind, parallel-group, active-controlled non-inferiority trial. A total of 406 subjects with diabetic macular edema (DME) were planned for enrollment.
- Trial name
- NCT07515079
- Testing
- BAT5906 injection, Lucentis
- Where
- 50 sites in China
- Volunteers
- 406 people
- Sponsor
- Bio-Thera Solutions
Diabetic Macular Edema
Study of Two Multiple Intravitreal Doses of BAT5906 for Safety and Efficacy in Patients With Diabetic Macular Edema
This study is a multi-center, open, multiple-dose phase Ib/IIa clinical study evaluating the efficacy and safety of BAT5906 injection in patients with diabetic macular edema.
- Trial name
- NCT04772105
- Testing
- 2.5mg of BAT5906, 4.0mg of BAT5906
- Where
- 19 sites in China
- Volunteers
- 60 people
- Sponsor
- Bio-Thera Solutions
Diabetic Macular Edema, Uveitic Macular Edema
A Study to Investigate RO7200220 as Monotherapy and in Combination With Ranibizumab in Participants With Diabetic and Uveitic Macular Edema
The purpose of this study was to assess the safety and tolerability of RO7200220 as monotherapy (diabetic macular edema [DME] or uveitic macular edema [UME] population) and in combination with ranibizumab (DME population only).
- Trial name
- DOVETAIL (NCT06771271)
- Testing
- RO7200220, Ranibizumab
- Where
- 19 sites in United States
- Volunteers
- 85 people
- Sponsor
- Hoffmann-La Roche
Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema
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)
The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with…
- Trial name
- NCT01997164
- Testing
- REGN910-3, REGN910, Intravitreal Aflibercept Injection (IAI)
- Where
- 5 sites in United States
- Volunteers
- 20 people
- Sponsor
- Regeneron Pharmaceuticals
Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema
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)
This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular…
- Trial name
- ELARA (NCT06491914)
- Testing
- Aflibercept 8 mg
- Where
- 54 sites in United States, Puerto Rico
- Volunteers
- 1,126 people
- Sponsor
- Regeneron Pharmaceuticals
Diabetic Macular Edema
Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.
The purpose of this study is to generate additional safety and effectiveness data in Indian Diabetic macular edema (DME) patients that more closely resemble the real-world population intended to be treated with Brolucizumab.
- Trial name
- NCT05959304
- Testing
- brolucizumab
- Where
- 8 sites in India
- Volunteers
- 66 people
- Sponsor
- Novartis Pharmaceuticals
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
Macular Edema, Macular Degeneration
Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced Out Follow-up After Intensive Treatment Phase
The study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after…
- Conditions
- Macular Edema, Macular Degeneration, Diabetes
- Trial name
- CONSTELLATION (NCT02032173)
- Testing
- Ranibizumab 0.5mg
- Where
- 10 sites in France
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Diabetic Retinopathy, Diabetic Macular Edema
Prevalence of DIAbetic RETinopathy and Impact of Genetic Factors in the Development of Diabetic Retinopathy of Patients With Type 1 and 2 Diabetes Mellitus in SlovaKia
The aim of the study is to find out prevalence and individual stages of Diabetic Retinopathy in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements in Slovak Republic.
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema, Diabetes Mellitus
- Trial name
- DIARET SK (NCT02232503)
- Testing
- Studied cohort
- Volunteers
- 4,011 people
- Sponsor
- Novartis Slovakia, s.r.o.
Diabetic Macular Edema (DME)
A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME
EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig (EYE103) in comparison with the active control, ranibizumab, in patients with diabetic macular edema…
- Trial name
- BAROLO (NCT06957080)
- Testing
- Remigromig, Ranibizumab
- Where
- 164 sites in United States, Argentina and 4 more
- Volunteers
- 1,054 people
- Sponsor
- EyeBiotech Ltd.
Diabetic Macular Edema, Branch Retinal Vein Occlusion
EffiCacy, Safety and ToLErability of a Novel Ocular ANtiseptic for Ocular Use (CLEAN)
This is a randomized, double-masked, multicenter, study to evaluate the efficacy, safety, and tolerability of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections.
- Conditions
- Diabetic Macular Edema, Branch Retinal Vein Occlusion, Glaucoma/Closed Angle Glaucoma
- Trial name
- CLEAN (NCT05127525)
- Testing
- IRX-101, Control
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- iRenix Medical, Inc.
Diabetic Macular Oedema, Retinal Vein Occlusion with Macular Oedema
Safety and Efficacy of IBE-814 Intravitreal (IVT) Implant - a Sustained, Low Dose Dexamethasone Therapy
This trial is a phase II, multi-center, single-masked (assessors) dose-ranging study designed to evaluate the comparative safety and preliminary efficacy of two dosage regimens of the IBE-814 IVT Dexamethasone Implant in patients…
- Trial name
- NCT04576689
- Testing
- IBE-814 70ug, IBE-814 140ug
- Where
- 21 sites in Australia, Canada and 2 more
- Volunteers
- 60 people
- Sponsor
- Ripple Therapeutics Pty Ltd
Diabetic Macular Edema
Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema
The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS)…
- Trial name
- VISTA DME (NCT01363440)
- Testing
- Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321), Macular Laser Photocoagulation
- Where
- 51 sites in United States
- Volunteers
- 466 people
- Sponsor
- Regeneron Pharmaceuticals
Diabetic Macular Edema
Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.
- Trial name
- NCT01304706
- Testing
- Fluocinolone Acetonide
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Alimera Sciences
Diabetic Macular Edema
Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)
To evaluate, specifically within the Canadian medical environment, the efficacy, safety and cost-efficacy of ranibizumab administered either as combination therapy (ranibizumab plus laser photocoagulation), or as monotherapy in…
- Trial name
- RESPOND (NCT01135914)
- Testing
- ranibizumab, Laser
- Where
- 20 sites in Canada
- Volunteers
- 241 people
- Sponsor
- Novartis Pharmaceuticals