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Neovascular Age-related Macular DegenerationPhase 4TRISTARNCT03468296

Two-week Retreatment Interval Study for Treated Age-related Macular Degeneration Refractory to Monthly Aflibercept

A Phase 4 study testing Intravitreal Aflibercept Injection 2mg in people with Neovascular Age-related Macular Degeneration, run by Tennessee Retina at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Intravitreal Aflibercept Injection 2mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Apr 2018to Jul 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 50 years
  • A diagnosis of choroidal neovascularization related to age-related macular degeneration
  • ETDRS refracted BCVA ≥ 20/200
  • Prior treatment with any anti-VEGF agent for ≥ 12 months
  • Prior treatment with at least five intravitreal aflibercept at the time of screening (week -2) with an average inter-treatment interval <35 days
  • Presence of persistent subretinal fluid with or without intraretinal fluid on OCT at most recent standard of care visit occurring 28-35 days following most recent intravitreal aflibercept injection
Show all 28Show fewer
  • Demonstration of definite improvement in overall retinal thickness and/or subretinal fluid on OCT based on evaluation of examining investigator at screening visit (week -2) 13-15 days following most recent standard of care visit
  • o Note: screening OCT will be performed prior to dilation to allow for undilated ETDRS BCVA testing following confirmation of eligibility
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent
  • Ocular Exclusion Criteria:
  • Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
  • Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
  • Concurrent eye disease in the study eye that could compromise visual acuity (e.g. advanced diabetic retinopathy, advanced glaucoma)
  • Active intraocular inflammation (grade trace or above) in the study eye
  • Current vitreous hemorrhage in the study eye
  • History of macula-involving rhegmatogenous retinal detachment or macular hole (Stage 2 - 4) in the study eye
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Aphakia in the study eye
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
  • Systemic Exclusion Criteria
  • Use of systemic anti-VEGF medications within 6 months of screening visit
  • History of cerebrovascular accident, myocardial infarction, ventricular arrhythmia, unstable angina, coronary or peripheral artery bypass or stenting within 6 months of day 0
  • History of deep vein thrombosis or pulmonary embolus within 6 months of day 0
  • Uncontrolled hypertension (>160/100 on medical treatment)
  • Pregnant or breast-feeding women
  • Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception prior to the initial dose administration (baseline visit, week 0). 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; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.
  • Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tennessee Retina

    Nashville, Tennessee, 37203

    Eric Schneider, MD, 615-983-6000, eschneider@tnretina.com

    Carl Awh, MD

Other trials in United States

About this study

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.

Read the detailed description

Eligible patients will be scheduled to receive intravitreal aflibercept (2.0mg) injections for six consecutive 2 week (13-15 days) intervals with injections administered at weeks 0, 2, 4, 6, 8, 10, and 12. The primary endpoint visit to assess response to sustained q2week therapy will be at the week 14 visit. No treatment will be administered at this visit. All patients will then return at week 16 for the randomization visit and receive a repeat intravitreal aflibercept (2.0mg) injection. For purposes of randomization, patients will be separated into the following groups:

  • Q2 week complete responders: absence of subretinal fluid on OCT at week 16
  • Q2 week incomplete responders: persistent subretinal fluid on OCT at week 16

The "q2 week complete responders" will subsequently be transitioned to a treat and extend regimen with a minimum inter-treatment interval of 4 weeks through week 24. The "q2 week incomplete responders" will be randomized in a 1:1 fashion into one of two arms:

  • Continued q2 week treatment: intravitreal aflibercept (2.0mg) injections for an additional four consecutive 2 week intervals at weeks 18, 20, 22, and 24
  • Transition to treat-and-extend treatment: through week 24 with a minimum inter-treatment interval of q4 weeks. This arm is identical to regimen for "q2 week complete responders."

Beginning in week 24, all patients (all groups) will undergo treatment delivered on a treat-and-extend basis with a minimum inter-treatment interval of 4 weeks through the week 50. Patient visits will be treated no more frequent than q4 weeks during treat-and-extend portions of the protocol.

All patients will have a mandatory study termination visit at week 52 (-1/+2 weeks). No study treatment will be administered after week 50. Patients receiving a study treatment after week 48 will return 4 weeks after this final study treatment for study termination visit. Patients receiving a study treatment at or before week 48 in whom the treat-and-extend protocol would dictate a subsequent visit after week 52 will instead return at week 52 for a study termination visit.

Being tested
Intravitreal Aflibercept Injection 2mg
Keywords
age-related macular degeneration
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravitreal Aflibercept Injection 2mgDrug

    Also called Aflibercept; EYLEA®; VEGF Trap-Eye

    Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration.

Study groups in NCT03468296
Study groupRoleWhat they receive
Continued Q2 Week TreatmentExperimentalWill receive intravitreal aflibercept (2.0mg) injections for an additional four consecutive 2 week intervals at weeks 18, 20, 22, and 24
Receives: Drug: Intravitreal Aflibercept Injection 2mg
Treat-And-Extend TreatmentActive comparatorWill receive intravitreal aflibercept (2.0mg) injections on a treat-and-extend basis through week 24 with a minimum inter-treatment interval of q4 weeks.
Receives: Drug: Intravitreal Aflibercept Injection 2mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Frequency and severity of ocular and systemic adverse events

    Measured: Through Week 14

Secondary outcomes (9)

  1. Retinal Thickness

    Central Subfield Thickness on Optical Coherence Tomography

    Measured: Weeks 14, 16, 24, 52

  2. Subretinal Fluid Height

    Max subretinal fluid height week on Optical Coherence Tomography

    Measured: Weeks 14, 16, 24, 52

  3. Pigment Epithelial Detachment Height

    Max pigment epithelial detachment height on Optical Coherence Tomography

    Measured: Weeks 14, 16, 24, 52

  4. Proportion of Dry Maculas

    Proportion of eyes with a dry macula (no subretinal fluid on Optical Coherence Tomography)

    Measured: Weeks 14, 16, 24, 52

  5. Best-Corrected Visual Acuity

    Mean best-corrected visual acuity

    Measured: Weeks 14, 24, and 52

  6. Change in Best-Corrected Visual Acuity

    Mean change in best-corrected visual acuity from baseline

    Measured: Weeks 14, 24, and 52

  7. Proportion gaining >5 letters of Best-Corrected Visual Acuity

    Proportion of eyes gaining > 5 letters

    Measured: Weeks 14, 24, and 52

  8. Treatment Burden

    Mean number of injections administered

    Measured: Through Week 52

  9. Ability to Extend Treatment Interval

    Proportion of eyes able to be extended during treat-and-extend dosing

    Measured: Through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2018
  2. Study startApr 2018 (estimated)
  3. Primary completionOct 2018 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03468296
Sponsor's protocol ID
VGFTe-AMD-1819
Acronym
TRISTAR
Status last verified
Mar 2018
First submitted
8 Mar 2018
Last updated
20 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schneider EW, Thomas MK, Recchia FM, Reichstein DA, Awh CC. SUSTAINED BIWEEKLY AFLIBERCEPT FOR REFRACTORY NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: The Prospective TRISTAR Study. Retina. 2023 May 1;43(5):739-746. doi: 10.1097/IAE.0000000000003729.

    PubMed 36728874

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravitreal Aflibercept Injection 2mg in people with Neovascular Age-related Macular Degeneration, run by Tennessee Retina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Through Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03468296, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.

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