Clinical trials: Center-Involved Diabetic Macular Edema
Diabetic Macular Edema
A Study to Evaluate the Safety and Tolerability of EXN407
This first in human (FIH), Phase Ib/II study of EXN407 is a randomised, double-masked, vehicle-controlled, multiple dose, dose-escalating study to evaluate the safety and tolerability of EXN407 in subjects with centre involved…
- Trial name
- NCT04565756
- Testing
- EXN407
- Where
- 11 sites in Australia
- Volunteers
- 48 people
- Sponsor
- Exonate Limited
Diabetic Retinopathy
A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.
The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe Non-proliferative…
- Trial name
- ROBIN (NCT03238963)
- Testing
- BI 1467335
- Where
- 35 sites in United States, Austria and 6 more
- Volunteers
- 79 people
- Sponsor
- Boehringer Ingelheim
Diabetic Macular Edema
Treatment for CI-DME in Eyes With Very Good VA Study
Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes…
- Trial name
- Protocol V (NCT01909791)
- Testing
- Prompt Laser, Prompt aflibercept, Deferred laser
- Where
- 103 sites in United States, Canada
- Volunteers
- 702 people
- Sponsor
- Jaeb Center for Health Research
Diabetic Macular Edema
Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)
This is a clinical study where patients with diabetes and a vision threatening eye condition called "Diabetic Macular Edema" receive four injections into the eye at monthly intervals.
- Trial name
- NCT03466099
- Testing
- KVD001 Injection
- Where
- 35 sites in United States
- Volunteers
- 129 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
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 Retinopathy
A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Diabetes affects 30.3 million people or 9.3% of the population of the United States. Results of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes patients have some degree of diabetic retinopathy…
- Trial name
- NCT02963441
- Testing
- LumineticsCore (formerly IDX-DR)
- Volunteers
- 900 people
- Sponsor
- Digital Diagnostics, Inc.
Diabetic Retinopathy
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.
- Trial name
- NCT00090519
- Testing
- ruboxistaurin
- Where
- 84 sites in United States, Australia and 15 more
- Volunteers
- 731 people
- Sponsor
- Chromaderm, Inc.
Diabetic Macular Edema
NSAID Phase II for Non-central Involved Diabetic Macular Edema (DME)
This study is being conducted to assess the effects of topical nonsteroidal anti-inflammatories (NSAIDs) on macular retinal volume compared with placebo in eyes with non-central diabetic macular edema (DME).
- Trial name
- NCT01331005
- Testing
- nepafenac 0.1% drops, Nepafenac Vehicle
- Where
- 32 sites in United States
- Volunteers
- 125 people
- Sponsor
- Jaeb Center for Health Research
Diabetic Macular Edema
A Randomized, Multi-center, Phase II Study of the Safety, Tolerability and Bioactivity of Repeated Intravitreal Injections of iCo-007 as Monotherapy or in Combination With Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema (the iDEAL Study)
To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation To assess the change in visual…
- Trial name
- iDEAL (NCT01565148)
- Testing
- iCo-007 350 mcg, iCo-007 700 mcg, iCo-007 350 mcg and Laser
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- Johns Hopkins University
Diabetic Macular Edema
A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (DME).
- Trial name
- BOULEVARD (NCT02699450)
- Testing
- Faricimab, Ranibizumab
- Where
- 60 sites in United States
- Volunteers
- 229 people
- Sponsor
- Hoffmann-La Roche
Diabetic Macular Edema
DRCR.Net Aflibercept vs. Bevacizumab + Deferred Aflibercept for the Treatment of CI-DME
Both aflibercept and bevacizumab have been shown to improve vision in eyes with DME. In eyes with DME and at least moderate vision loss, both aflibercept and bevacizumab were also shown to be successful in many eyes.
- Trial name
- DRCR AC (NCT03321513)
- Testing
- intravitreous aflibercept, Bevacizumab + Deferred Aflibercept Group
- Where
- 54 sites in United States
- Volunteers
- 270 people
- Sponsor
- Jaeb Center for Health Research
Diabetic Macular Edema, Hard Lipid Exudates
The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
- Trial name
- NCT02448446
- Testing
- ranibizumab 0.3mg
- Where
- 4 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- South Coast Retina Center; Carson, McBeath, Boswell, Inc.
Diabetic Retinopathy, Macula Edema
Transfoveal Micropulse Laser for Center Involving Diabetic Macular Edema
Anti-vascular endothelial growth factor (VEGF) therapy is currently the mainstay of treatment for diabetic macular edema (DME). One of the main obstacles of anti-VEGF therapy is the need of repeated injections, which carries both…
- Trial name
- NCT04359771
- Testing
- Yellow micro-pulse laser, Diode micro-pulse laser
- Where
- Egypt
- Volunteers
- 15 people
- Sponsor
- Cairo University
Macular Edema Associated With Diabetes Mellitus
A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.
The purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy.
- Trial name
- NCT00605280
- Testing
- Standard of Care, Macugen
- Where
- 73 sites in United States, Australia and 16 more
- Volunteers
- 317 people
- Sponsor
- Pfizer
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 Retinopathy
A Multicenter, Randomized Study in Participants With Diabetic Retinopathy Without Center-involved Diabetic Macular Edema To Evaluate the Efficacy, Safety, and Pharmacokinetics of Ranibizumab Delivered Via the Port Delivery System Relative to the Comparator Arm
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…
- Trial name
- PAVILION (NCT04503551)
- Testing
- PDS Implant Pre-Filled with 100 mg/mL Ranibizumab, Intravitreal Ranibizumab 0.5 mg Injection
- Where
- 65 sites in United States, Puerto Rico
- Volunteers
- 174 people
- Sponsor
- Hoffmann-La Roche
Diabetic Macular Edema
Phase II Combination Steroid and Anti-VEGF for Persistent DME
Although anti-vascular endothelial growth factor (VEGF) therapy is generally effective as treatment for center-involved diabetic macular edema (DME), a substantial proportion of anti-VEGF-treated eyes with DME do not achieve…
- Trial name
- NCT01945866
- Testing
- intravitreal ranibizumab 0.3 mg, dexamethasone intravitreal implant
- Where
- 56 sites in United States
- Volunteers
- 129 people
- Sponsor
- Jaeb Center for Health Research
Macular Edema
Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement
To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular…
- Trial name
- VIVID EAST (NCT01783886)
- Testing
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321), Macular Laser Photocoagulation
- Where
- 25 sites in China, Hong Kong and 2 more
- Volunteers
- 381 people
- Sponsor
- Bayer
Macular Edema
Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema
This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision…
- Trial name
- NCT02732951
- Testing
- BI 1026706
- Where
- 35 sites in Belgium, France and 6 more
- Volunteers
- 105 people
- Sponsor
- Boehringer Ingelheim