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Monoclonal Antibodies

Continued Q2 Week Treatment for Age-Related Macular Degeneration (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

TRISTAR Trial 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
  • Age-Related Macular Degeneration

TRISTAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 14, 16, 24, 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 14, 16, 24, 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Secondary outcome measures
Ability to Extend Treatment Interval
Best-Corrected Visual Acuity
Change in Best-Corrected Visual Acuity
+6 more

Side effects data

From 2013 Phase 3 trial • 323 Patients • NCT00964795
11%
Retinal Haemorrhage
9%
Conjunctival Haemorrhage
9%
Age-Related Macular Degeneration
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%
Pneumonia
2%
Urinary Tract Infection
2%
Cerebrovascular Accident
2%
Acute Myocardial Infarction
2%
Syncope
1%
Splenic Rupture
1%
Hip Fracture
1%
Humerus Fracture
1%
Accident
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

TRISTAR 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
Regeneron PharmaceuticalsIndustry Sponsor
619 Previous Clinical Trials
380,233 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Two-week Retreatment Interval Study for Treated Age-related Macular Degeneration Refractory to Monthly Aflibercept
2018. "Two-week Retreatment Interval Study for Treated Age-related Macular Degeneration Refractory to Monthly Aflibercept". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03468296.
All > Age Related Macular Degeneration > Macular Degeneration
~3 spots leftby Apr 2025
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