Clinical trials: Diabetic Macular Oedema
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
Diabetes, Diabetic Macular Edema
OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits
The purpose of this protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina…
- Conditions
- Diabetes, Diabetic Macular Edema, Diabetic Retinopathy
- Trial name
- DME FOUND (NCT01875783)
- Testing
- OCT imaging
- Where
- 4 sites in United States
- Volunteers
- 385 people
- Sponsor
- Joslin Diabetes Center
Diabetic Retinopathy, Diabetic Macular Edema
Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy
The objective of this study is to evaluate the safety and efficacy of APX3330 to treat diabetic retinopathy (DR) and diabetic macular edema (DME).
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema, NPDR - Non Proliferative Diabetic Retinopathy, PDR - Proliferative Diabetic Retinopathy
- Trial name
- ZETA-1 (NCT04692688)
- Testing
- APX3330
- Where
- 24 sites in United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Opus Genetics, 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
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
- Trial name
- FAME (NCT00344968)
- Testing
- fluocinolone acetonide, Standard of care laser photocoagulation
- Where
- United States
- Volunteers
- 956 people
- Sponsor
- Alimera Sciences
Diabetic Macular Edema
Efficacy & Safety Trial of Intravitreal Injections Combined With PRP for CSME Secondary to Diabetes Mellitus (DAVE)
This study is a Phase I/II, multicenter, randomized, study of the efficacy and safety of ranibizumab injection monotherapy verses a duel therapy of 0.3mg ranibizumab combined with ultra wide, 200° field angiography guided pan…
- Trial name
- DAVE (NCT01552408)
- Testing
- 0.3 mg ranibizumab, Targeted Pan Retinal Photocoagulation
- Where
- 3 sites in United States
- Volunteers
- 29 people
- Sponsor
- David M. Brown, M.D.
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
Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema
Anti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid and or vascular endothelial growth factor…
- Trial name
- NCT05343156
- Testing
- Dexamethasone nanoparticles eye drops
- Where
- Denmark
- Volunteers
- 144 people
- Sponsor
- Oculis
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 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
Neovascular Age-related Macular Degeneration, Age-related Macular Degeneration
SD-OCT Angiography
The objective of this study is to image retinal vascular alterations in patients with retinal disease using the AngioVue OCT-A system and understand the information these images provide.
- Conditions
- Neovascular Age-related Macular Degeneration, Age-related Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion
- Trial name
- NCT02510885
- Testing
- AngioVue SD-OCT
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Duke University
Diabetic Macular Edema
Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema
Phase III clinical study to evaluate the efficacy, expressed as improvement in visual acuity in patients suffering diabetic macular edema after one year of treatment with PRO-169, compared to treatment with Lucentis®…
- Trial name
- PRO-169 (NCT05217680)
- Testing
- Bevacizumab, Lucentis®
- Where
- Mexico
- Volunteers
- 509 people
- Sponsor
- Laboratorios Sophia S.A de C.V.
Diabetic Retinopathy, Diabetic Macular Edema
Evaluation of Vitrectomy for Diabetic Macular Edema
The study is designed as a prospective cohort study to assess changes in visual acuity and retinal thickening and surgical complications in subjects undergoing vitrectomy for diabetic macular edema.
- Trial name
- Vitrectomy-D (NCT00709319)
- Where
- 48 sites in United States
- Volunteers
- 87 people
- Sponsor
- Jaeb Center for Health Research
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
Age-Related Macular Degeneration, Geographic Atrophy
Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO
To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO. The study will assess variability across measurements taken by three different operator-device configuration across clinical sites…
- Conditions
- Age-Related Macular Degeneration, Geographic Atrophy, Diabetic Retinopathy, Macular Edema
- Trial name
- NCT01692938
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Optos, PLC
Diabetic Macular Edema
A Study to Investigate Aqueous Humor and Multimodal Imaging Biomarkers in Treatment-Naïve Participants With Diabetic Macular Edema Treated With Faricimab
This is an exploratory, prospective, multicenter, open-label, single-arm, interventional, Phase IIb study designed to explore the associations over time between clinical assessments, multimodal imaging assessments, aqueous humor…
- Trial name
- ALTIMETER (NCT04597918)
- Testing
- Faricimab
- Where
- 23 sites in United States, Argentina and 5 more
- Volunteers
- 99 people
- Sponsor
- Hoffmann-La Roche
Diabetic Macular Edema, Ischemic Maculopathy
Evaluation of the Effect of Intravitreal Injections of Anti-VEGF on Macular Perfusion in Diabetic Patients Using OCTA
Anti-vascular endothelial growth factor (VEGF) drugs are the mainstay of therapy for diabetic macular edema (DME), substantially improving visual acuity for many diabetics worldwide, and proving effective for treatment of both…
- Trial name
- IMPACT (NCT03246152)
- Testing
- Bevacizumab
- Where
- Egypt
- Volunteers
- 31 people
- Sponsor
- Cairo University
Age-related Macular Degeneration, Central Retinal Vein Occlusion
Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival
Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at increasing rates.
- Conditions
- Age-related Macular Degeneration, Central Retinal Vein Occlusion, Diabetic Macular Edema
- Trial name
- NCT01640171
- Testing
- Xylocaine 2% Injectable Anesthetic, Proparacaine Hydrochloride 0.5% Drop, Tetravisc 0.5% Gel
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Retina Vitreous Associates of Florida
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
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.
- Trial name
- NCT00168337
- Testing
- Dexamethasone
- Where
- 14 sites in United States, Brazil and 12 more
- Volunteers
- 554 people
- Sponsor
- Allergan