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Monoclonal Antibodies
Two-week Retreatment Interval Study for Treated Age-related Macular Degeneration Refractory to Monthly Aflibercept (TRISTAR Trial)
Phase 4
Waitlist Available
Research Sponsored by Tennessee Retina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 14, 16, 24, 52
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved
Summary
This study is designed to evaluate the safety and efficacy of every 2 week intravitreal aflibercept injections in a population of neovascular AMD patients that have demonstrated refractory subretinal fluid with or without intraretinal fluid despite prior monthly intravitreal aflibercept treatment.
Eligible Conditions
- Macular Degeneration
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 14, 16, 24, 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 14, 16, 24, 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Secondary study objectives
Ability to Extend Treatment Interval
Best-Corrected Visual Acuity
Change in Best-Corrected Visual Acuity
+6 moreSide effects data
From 2013 Phase 3 trial • 323 Patients • NCT0096479511%
Retinal Haemorrhage
9%
Age-Related Macular Degeneration
9%
Conjunctival Haemorrhage
9%
Hypertension
7%
Fall
7%
Nausea
7%
Nasopharyngitis
6%
Posterior Capsule Opacification
6%
Bronchitis
6%
Upper Respiratory Tract Infection
5%
Arthralgia
5%
Cataract
5%
Retinal Detachment
4%
Atrial Fibrillation
2%
Urinary Tract Infection
2%
Pneumonia
2%
Cerebrovascular Accident
2%
Acute Myocardial Infarction
2%
Syncope
1%
Splenic Rupture
1%
Hip Fracture
1%
Accident
1%
Humerus Fracture
1%
Osteoarthritis
1%
Lung Adenocarcinoma
1%
Rectal Adenocarcinoma
1%
Pulmonary Embolism
1%
Chronic Obstructive Pulmonary Disease
1%
Sepsis
1%
Spinal Osteoarthritis
1%
Breast Cancer
1%
Angina Pectoris
1%
Arrhythmia
1%
Cardiac Arrest
1%
Cardiac Failure Acute
1%
Cardiac Failure Congestive
1%
Coronary Artery Disease
1%
Myocardial Infarction
1%
Diarrhoea
1%
Pancreatitis
1%
Vomiting
1%
Cellulitis
1%
Facial Bones Fracture
1%
Femoral Neck Fracture
1%
Dehydration
1%
Endophthalmitis
1%
Femur Fracture
1%
Anaemia
1%
Transient Ischaemic Attack
1%
Mental Status Changes
1%
Renal Failure Acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-label Intravitreal Aflibercept Injection
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Continued Q2 Week TreatmentExperimental Treatment1 Intervention
Will receive intravitreal aflibercept (2.0mg) injections for an additional four consecutive 2 week intervals at weeks 18, 20, 22, and 24
Group II: Treat-And-Extend TreatmentActive Control1 Intervention
Will receive intravitreal aflibercept (2.0mg) injections on a treat-and-extend basis through week 24 with a minimum inter-treatment interval of q4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept
FDA approved
Find a Location
Who is running the clinical trial?
Tennessee RetinaLead Sponsor
2 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Macular Degeneration
30 Patients Enrolled for Macular Degeneration
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,802 Total Patients Enrolled
46 Trials studying Macular Degeneration
24,523 Patients Enrolled for Macular Degeneration