Wet Age-related Macular Degeneration Clinical Trial
Official title:
A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration
Verified date | February 2022 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)
Status | Completed |
Enrollment | 64 |
Est. completion date | October 18, 2018 |
Est. primary completion date | October 18, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Active subfoveal NVAMD Exclusion Criteria: - History or evidence of severe cardiac disease - Any major surgical procedure within one month of trial entry - Subjects with a clinically significant laboratory value - Any treatment with an investigational agent in the past 60 days for any condition - Women who are pregnant or nursing - Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation - Any prior treatment for AMD other than oral supplements of vitamins and minerals |
Country | Name | City | State |
---|---|---|---|
Hungary | Budapest Retina Associates | Budapest | |
Hungary | Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont | Budapest | |
Hungary | Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika | Szeged | |
Latvia | Dr. Solomatin's eye rehabilitation and vision correction centre | Riga | |
Latvia | Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology | Riga | |
United States | Retina Research Institute of Texas | Abilene | Texas |
United States | Florida Eye Clinic | Altamonte Springs | Florida |
United States | Retina-Vitreous Associates Medical Group | Beverly Hills | California |
United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
United States | Retina Consultants of Orange County | Fullerton | California |
United States | Colorado Retina Associates | Golden | Colorado |
United States | Retina Consultants of Nevada | Henderson | Nevada |
United States | Charleston Neuroscience Institute | Ladson | South Carolina |
United States | Florida Eye Associates | Melbourne | Florida |
United States | VitreoRetinal Surgery | Minneapolis | Minnesota |
United States | Illinois Eye Center | Peoria | Illinois |
United States | Mid Atlantic Retina | Philadelphia | Pennsylvania |
United States | Retinal Research Institute | Phoenix | Arizona |
United States | Retina Northwest PC | Portland | Oregon |
United States | Retina Consultants of Southern California | Redlands | California |
United States | Sierra Eye Associates | Reno | Nevada |
United States | Retinal Consultants Medical Group | Sacramento | California |
United States | Orange County Retina Medical Group | Santa Ana | California |
United States | Retina Vitreous Surgeons of CNY, PC | Syracuse | New York |
United States | Retina Associates SW, PC | Tucson | Arizona |
United States | Retina Centers PC | Tucson | Arizona |
United States | Vitreo Retinal Consultants & Surgeons | Wichita | Kansas |
United States | Strategic Clinical Research Group | Willow Park | Texas |
Lead Sponsor | Collaborator |
---|---|
Ophthotech Corporation |
United States, Hungary, Latvia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change From Baseline - ECG | Number of patients with a change on their Month 6 ECG when compared to their baseline ECG | 6 months | |
Other | Mean Change From Baseline - Study Eye ETDRS Visual Acuity | Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning. | 6 months | |
Other | Mean Change From Baseline - Vital Signs | Mean change from Baseline to Month 6 in blood pressure (mm Hg). A negative number indicates a decrease and a positive number indicates an increase. | 6 months | |
Primary | Systemic Adverse Events | Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage) | 6 months | |
Primary | Ophthalmic Adverse Events | Number of participants with ophthalmic Adverse Events (with calculated percentage) | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00138632 -
Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Terminated |
NCT04594681 -
A Safety Study of KHK4951 in Healthy Volunteers and Patients With Wet Age-Related Macular Degeneration
|
Phase 1 | |
Completed |
NCT03585556 -
AAVCAGsCD59 for the Treatment of Wet AMD
|
Phase 1 | |
Not yet recruiting |
NCT04564937 -
The Study of Drug SCT510A in Patients With Wet Age-related Macular Degeneration (wAMD)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04504123 -
MMP-9 Inhibition for Recalcitrant Wet AMD
|
Phase 2 | |
Terminated |
NCT02005133 -
A Prospective, Observational, Multicentre, 2 Year Study Evaluating the Use of Eylea (Aflibercept) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration in UK NHS Opthalmology Clinics
|
N/A | |
Completed |
NCT01016873 -
INTREPID - IRay Plus Anti-VEGF Treatment For Patients With Wet AMD
|
Phase 2 | |
Completed |
NCT03748784 -
ADVM-022 Intravitreal Gene Therapy for Wet AMD
|
Phase 1 | |
Recruiting |
NCT04468997 -
The Study of Drug 601 in Patients With Wet Age-related Macular Degeneration (wAMD)
|
Phase 1 | |
Completed |
NCT04685369 -
Effectiveness of Anti-VEGF Treatments in Wet AMD in Active Smokers
|
||
Enrolling by invitation |
NCT04932980 -
Comparison of Rapid Aflibercept and Brolucizumab T&E in wAMD
|
N/A | |
Recruiting |
NCT05297292 -
A Study to Evaluate the Efficacy and Safety of MW02 in the Treatment of nAMD
|
Phase 2/Phase 3 | |
Completed |
NCT03939767 -
Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease
|
||
Completed |
NCT03066258 -
Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial
|
Phase 1/Phase 2 | |
Terminated |
NCT01086761 -
Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration
|
Phase 1 | |
Recruiting |
NCT05727397 -
Efficacy and Safety of RC28-E Versus Aflibercept
|
Phase 3 | |
Completed |
NCT04884399 -
Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD
|
Phase 1 | |
Completed |
NCT04964089 -
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
|
Phase 3 | |
Withdrawn |
NCT01339949 -
Study to Evaluate the Safety and Effectiveness of IRay in Wet Age-related Macular Degeneration (AMD) Patients With Recurrent Leakage Secondary to Choroidal Neovascularisation (CNV)
|
N/A | |
Terminated |
NCT00139282 -
A Safety and Efficacy Study of Squalamine Lactate for Injection (MSI-1256F) for "Wet" Age-Related Macular Degeneration
|
Phase 3 |