Polypoidal Choroidal Vasculopathy Clinical Trial
— EPICOfficial title:
Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation
Verified date | November 2016 |
Source | Hawaii Pacific Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To evaluate the efficacy and safety of intravitreal aflibercept injection in the treatment of PCV
Status | Completed |
Enrollment | 25 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 25 Years and older |
Eligibility |
Inclusion Criteria: - Age > 25 years of age. - In the opinion of the principal investigator, the study eye has PCV with active exudation and/or bleeding that may benefit from treatment with study medication. - Diagnosis of PCV via ICG Angiography with evidence of active leakage, active bleeding or recent decreased in vision. - Baseline visual acuity better than or equal to 20/200 using ETDRS - Willing and able to comply with clinic visits and study-related procedures - Provide signed informed consent Exclusion Criteria: - Any history of previous vitrectomy - Previous cataract surgery within the preceding 2 months of Day 0 - Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye - Presence of any condition that would jeopardize the patient's participation in this study - Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry - For the Treatment-Naïve cohort: no prior anti-VEGF (Macugen, Avastin, Lucentis, Eylea) in the study eye - For the Previous-Treated cohort: no prior anti-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days or enrollment in this study - For the Previous-Treated cohort: no prior Eylea in the study eye - Known allergy to any component of the study drug - Blood pressure >180/119 (systolic above 180 or diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, the patient can be eligible. - Major surgery within 28 days prior to randomization or major surgery planned within the next 12 months. Major surgery is defined as a surgical procedure that is more extensive than needle biopsy/aspiration placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter - Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization - Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization - Pregnant or breast-feeding women - Simultaneous participation in another medical investigational trial - Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Retina Consultants of Hawaii | Aiea | Hawaii |
Lead Sponsor | Collaborator |
---|---|
Gregg T. Kokame, MD | Regeneron Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficacy of intravitreal aflibercept injection of 2.0mg aflibercept | This study will evaluate the efficacy of intravitreal aflibercept injection of 2.0mg aflibercept administered Q8W following an initial loading dose of 3 monthly injections in patients with polypoidal choroidal vasculopathy with active exudation or bleeding as measured by: • Mean change in BCVA between Day 0 (Baseline) and Day 720 (M24) |
2 Years | No |
Secondary | Proportion of Patients with Stable, Improved, Significant Improved, Decreased, Significant Decreased Vision | To evaluate the proportion of patients at Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) with "Stable" vision <5 letters gained or lost, "Improved" vision >5 letters gained, "Significant Improved" vision =15 letters gained, "Decreased" vision >5 letters lost, "Significant Decreased" vision =15 letters lost | 6 Months, 12 Months, 18 Months, 24 Months | No |
Secondary | Proportion of Patients with decrease in Subretinal Hemorrhage and/or Exudates | To evaluate the proportion of patients at Day 180 (M6), Day 360 (M12), Day 540 (M18), Day 720 (M24) in decreasing subretinal hemorrhage and/or subretinal exudates via fundus photos and fundus exams | Month 6, Month 12, Month 18, Month 24 | No |
Secondary | Proportion of patients with decreased / complete resolution of Polypoidal Polyp. | To evaluate the proportion of subjects with a decrease and/or complete resolution of polypoidal polyps from PCV at Day 90 (M3), Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) as assessed by fluorescein and indocyanine green angiography | Month 3, Month 6, Month 12, Month 18, Month 24 | No |
Secondary | Proportion of subject with a decrease or complete resolution of branching vascular network from PCV | To identify the proportion of subjects with a decrease and/or complete resolution of branching vascular network (BVN) from PCV at Day 90 (M3), Day 180 (M6), Day 360 (M12), Day 540 (M18) and 720 (M24) months as assessed by fluorescein and indocyanine green angiography | Month 3, Month 6, Month 12, Month 18, Month 24 | No |
Secondary | Determine mean change in Central Foveal Thickness and/or peripapillary edema as measured by SD-OCT | To determine mean change in central foveal thickness (CFT) and/or peripapillary edema as measured by spectral domain optical coherence tomography (SD-OCT) in central and/or paracentral fields from Day 0 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18) and 720 (M24) | Baseline, Month 6, Month 12, Month 18, Month 24 | No |
Secondary | Mean Change in Choroidal Thickness | To determine mean change in choroidal thickness (at fovea) as imaged via EDI-OCT between Day 0 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18), and Day 720 (M24) | Baseline, Month 6, Month 12, Month 18, Month 24 | No |
Secondary | Proportion of previously treated and treatment naive patients that require additional dosing outside of the protocol determined dosing schedule | To identify proportion of patients between previously treated and treatment naïve patients that require additional dosing outside of the protocol determined dosing schedule: 3- initial monthly dosing followed by dosing every other month for 720 days (M24) | Month 24 | No |
Secondary | Assess changes on Autofluorescence | To assess changes on autofluorescence (AF) as seen on images from Day 1 (Baseline), Day 180 (M6), Day 360 (M12), Day 540 (M18) and Day 720 (M24) | Baseline, Month 6, Month 12, Month 18, Month 24 | No |
Secondary | Incidence and Severity of Ocular and Non-Ocular Adverse Events | To determine the incidence and severity of ocular and non-ocular adverse events from Day 1(Baseline) through the end of the study (Day 720) | Baseline through Month 24 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Active, not recruiting |
NCT01950741 -
Effect of Intravitreal VEGF-Trap Eye on Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
Completed |
NCT01469156 -
Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
|
Phase 1/Phase 2 | |
Recruiting |
NCT02597855 -
Comparison of the Short-term Outcomes of Intravitreal Aflibercept Injection Between Two Subtypes of Polypoidal Choroidal Vasculopathy Using Indocyanine Green Angiography
|
N/A | |
Completed |
NCT02495181 -
Randomized, Double-masked, Sham-controlled Phase 4 Study, Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
Active, not recruiting |
NCT02976194 -
Intraocular Cytokine in Recurrence of Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
Recruiting |
NCT01248117 -
Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy
|
Phase 1/Phase 2 | |
Completed |
NCT01884597 -
Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively (PEARL2)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04707027 -
Interval of Disease Inactivity After Complete Polypoidal Regression in PCV Receiving Aflibercept
|
N/A | |
Recruiting |
NCT02141308 -
OCT in Rare Chorioretinal Diseases
|
||
Completed |
NCT00470977 -
Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy
|
Phase 1/Phase 2 | |
Recruiting |
NCT00383812 -
Intravitreal Bevacizumab for Polypoidal Choroidal Vasculopathy
|
N/A | |
Completed |
NCT00837330 -
Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
|
Phase 1/Phase 2 | |
Completed |
NCT05229237 -
Conbercept for Polypoidal Choroidal Vasculopathy(START Study)
|
||
Not yet recruiting |
NCT04380974 -
Efficacy and Safety of Two Regimens of Anti-VEGF Therapy in Chinese Patients With Polypoidal Choroidal Vasculopathy
|
Phase 4 | |
Recruiting |
NCT02815176 -
Angiographic Characteristics of CSC, PCV Patients and Thrombotic Bio-markers
|
N/A | |
Active, not recruiting |
NCT00344617 -
Off-Label AVASTIN (BEVACIZUMAB) For Serosanguinous Maculopathy
|
Phase 3 | |
Recruiting |
NCT03929731 -
Long-term Outcomes, Recurrence Rates, and Treatment Needs in Polypoidal Choroidal Vasculopathy (PCV)
|
||
Completed |
NCT01023295 -
Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients With Polypoidal Choroidal Vasculopathy (PCV)
|
Phase 2 | |
Completed |
NCT02821520 -
Initial Versus Delayed PDT Combination With Conbercept in PCV
|
Phase 4 |