Clinical trials: Center-Involved Diabetic Macular Edema
Diabetic Retinopathy, Clinically Significant Macular Edema
Reduction of Foveal Sensitivity in Eyes With Diabetic Macular Edema
Clinically significant macular edema (CSME) is a thickening of the macula associated with the risk of visual loss, which increases its centre is involved.
- Trial name
- NCT01824862
- Where
- Mexico
- Volunteers
- 60 people
- Sponsor
- Hospital Juarez de Mexico
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 Retinopathy (DR), Center-Involved Diabetic Macular Edema (CI-DME)
RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)
ABBV-RGX-314 is being developed as a novel, potential one-time gene therapy treatment for the treatment of Diabetic Retinopathy (DR) with and without Center-Involved Diabetic Macular Edema (CI-DME).
- Trial name
- ALTITUDE® (NCT04567550)
- Testing
- ABBV-RGX-314 Dose 1, ABBV-RGX-314 Dose 2, ABBV-RGX-314 Dose 3
- Where
- 25 sites in United States
- Volunteers
- 139 people
- Sponsor
- AbbVie
Center-involved Diabetic Macular Edema (CI-DME)
Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema
This study will evaluate the effects of add-on carotenoid plus anti-oxidant nutritional supplementation to standard anti-vascular endothelial growth factor therapy for subjects with center-involved diabetic macular edema
- Trial name
- PROACTIVEDME (NCT03866005)
- Testing
- Diabetes Visual Function Study (DiVFuSS) softgels
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- ZeaVision, LLC
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
A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME
This is a Phase 1 study to investigate the safety, tolerability of the novel plasma kallikrein inhibitor, KVD001 in subjects with diabetic macular edema.
- Trial name
- NCT02193113
- Testing
- KVD001 Injection
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Diabetic Retinopathy
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina).
- Trial name
- NAAVIGATE (NCT07592273)
- Testing
- Surabgene Lomparvovec, Topical Steroid, Artificial Tears
- Where
- 38 sites in United States, Puerto Rico
- Volunteers
- 576 people
- Sponsor
- AbbVie
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 Retinopathy
Study to Evaluate Clinical Efficacy and Safety of Nuvastatic™ - C5OSEW5050ESA in Diabetic Retinopathy.
Diabetic retinopathy (DR) is a common complication of diabetes mellitus that leads to loss of vision and blindness among working age adults.
- Trial name
- NCT04552600
- Testing
- Nuvastatic
- Where
- India
- Volunteers
- 100 people
- Sponsor
- Natureceuticals Sdn Bhd
Center Involved Diabetic Macular Edema, Diabetic Macular Edema
Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
- Trial name
- DME (NCT05802329)
- Testing
- OCU200
- Where
- 5 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ocugen
Diabetic Macular Edema
Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab
The purpose of this study is to determine the efficacy of intravitreal aflibercept injections administered in a treat and extend fashion in eyes that have persistent center involved diabetic macular edema following at least 4…
- Trial name
- NCT03059277
- Testing
- Intravitreal Aflibercept
- Where
- 2 sites in United States
- Sponsor
- Southeast Clinical Research Associates, LLC
Diabetic Macular Edema, Center-involved Diabetic Macular Edema
Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients With Diabetic Macular Edema
The purpose of this clinical study is to explore the efficacy of dapagliflozin as an adjunct to intravitreal anti-vascular endothelial growth factor (anti-VEGF) for enhanced reduction of retinal thickness and vision improvement…
- Trial name
- DAPA-DME (NCT06845163)
- Testing
- Dapagliflozin, Anti-VEGF drug
- Where
- Egypt
- Volunteers
- 56 people
- Sponsor
- Alexandria University
Macular Edema, Macular Degeneration
Study Evaluating Retinal Health Monitoring System Thickness Module
Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).
- Trial name
- NCT04428242
- Testing
- RHMS-RTM, SD-OCT
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Kubota Vision Inc.
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
- United States
- Volunteers
- 180 people
- Sponsor
- BioAge Labs, Inc.
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, DR
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR with and without center involved-diabetic…
- Trial name
- NCT05296447
- Testing
- Standard of Care, Aflibercept
- Where
- 20 sites in United States
- Volunteers
- 100 people
- Sponsor
- AbbVie
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