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Age-related Macular Degeneration (ARMD)Phase 4NCT06683950

Switching to Aflibercept 8mg in Patients Showing Limited Response to Previous Treatment

A Phase 4 study testing Aflibercept 8mg in people with Age-related Macular Degeneration (ARMD), run by Kim's Eye Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The treatment landscape for neovascular AMD has evolved with various anti-VEGF agents since 2006. Ranibizumab initially led the way, but its limited efficacy in reducing retinal edema paved the way for aflibercept in 2011, which became globally popular for its effectiveness and safety. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-related Macular Degeneration (ARMD)
What is being tested?
Aflibercept 8mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteSouth Korea
Study dates
21 Oct 2024to 14 Jul 2026
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

  • Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
  • Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.
  • Signed informed consent
  • Patients aged 50 years or older
  • Patients diagnosed with neovascular AMD or PCV
  • Patients underwent faricimab or aflibercept 2mg injections with an inverval of 4 to 16 weeks
Show all 9Show fewer
  • Patients who continued to show persistent subretinal fluid (SRF) or intraretinal fluid (IRF) despite receiving two consecutive faricimab or aflibercept 2mg injections at the same injection interval.
  • In cases where the central retinal thickness did not decrease by more than 50 μm during two consecutive treatments prior to inclusion in the study
  • ETDRS BCVA letter score ≥25 letters (approximately 20/320 or better) in the study eye

Who cannot join

  • Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
  • Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography.
  • Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
  • Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
  • Any history of uveitis in either eye.
  • Presence of definite chorioretional anastomosis
Show all 20Show fewer
  • Scar or fibrosis, making up > 50% of total lesion in the study eye.
  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
  • Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
  • History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.
  • Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 76 week study period.
  • Prior vitrectomy in the study eye
  • Any history of macular hole of stage 2 and above in the study eye.
  • Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.
  • Prior trabeculectomy or other filtration surgery in the study eye.
  • Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
  • Active intraocular inflammation in either eye.
  • Active ocular or periocular infection in either eye.
  • Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] posterior capsulotomy) in the study eye.
  • History of corneal transplant or corneal dystrophy in the study eye.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kim's Eye Hospital

    Seoul, Seoul, 150-034

Other trials in South Korea

About this study

Official title: Efficacy of Switching to Aflibercept 8mg in Patients With Neovascular AMD Showing Limited Response to Faricimab or Aflibercept 2mg

The treatment landscape for neovascular AMD has evolved with various anti-VEGF agents since 2006. Ranibizumab initially led the way, but its limited efficacy in reducing retinal edema paved the way for aflibercept in 2011, which became globally popular for its effectiveness and safety. Yet, aflibercept did not fully meet all patients' needs. In 2019, brolucizumab showed promising anatomical results but had higher risks of inflammation, limiting its use. Faricimab, introduced in 2022, aimed for longer-lasting effects by targeting VEGF-A and angiopoietin 2. Though it required fewer injections, questions remain about its long-term efficacy compared to aflibercept.

Despite recent advancements, no agent has established itself as the new standard since aflibercept's introduction, leaving significant unmet needs. Aflibercept 8mg, approved in 2023, has shown promise by matching long-term visual outcomes of aflibercept 2mg with fewer injections and comparable safety. This study examines the effects of switching to aflibercept 8mg for patients with a limited response to previous treatments, addressing the potential for aflibercept 8mg to meet current needs more effectively and providing timely data for its global rollout.

Read the detailed description

The treatment of neovascular AMD with anti-VEGF agents has evolved significantly. Introduced in 2006, ranibizumab heralded the era of anti-VEGF therapies but had limitations in duration and effectiveness in reducing retinal edema. To overcome these issues, aflibercept was introduced in 2011 and has been recognized for its superior efficacy and safety,1 becoming the most widely used drug globally. However, aflibercept also showed limited response in some patients, and the duration of its effectiveness was not always satisfactory.

Brolucizumab, introduced in 2019, demonstrated excellent anatomical outcomes but had a relatively high incidence of intraocular inflammation, ranging from 3 to 10%, preventing it from becoming a widely accepted standard treatment. The most recent, faricimab, introduced in 2022, was developed to inhibit not only VEGF-A but also angiopoietin 2, aiming for longer-lasting effects. In the TENAYA/LUCERNE clinical trials comparing its efficacy and safety with aflibercept, faricimab showed similar effects with fewer injections. However, due to differences in the treatment protocols between the aflibercept and faricimab groups, there remains a question about whether faricimab truly offers a longer duration of effect.

In conclusion, despite the introduction of brolucizumab and faricimab over the long span of 13 years since aflibercept was first introduced, these drugs have struggled to establish themselves as the new standard agents, especially when considering their overall efficacy and safety. Consequently, there has been a significant accumulation of unmet needs in the clinical treatment landscape over this extended period.

Aflibercept 8mg, the most recently FDA-approved agent in 2023, demonstrated not only superior initial anatomical effects compared to aflibercept 2mg in the PULSAR study, but also achieved similar long-term visual outcomes with fewer injections. Furthermore, it exhibited excellent safety, comparable to that of aflibercept 2mg. Based on these outcomes, many experts anticipate that aflibercept 8mg will become the new standard agent in the treatment of neovascular AMD, officially succeeding aflibercept 2mg.

Excluding aflibercept 2mg, faricimab could be considered the strongest contender for establishing aflibercept 8mg as the new standard. This is attributed to faricimab demonstrating satisfactory effects and excellent safety in clinical trials, as well as in subsequent real-world studies. Currently, there are no head-to-head clinical trials comparing these two drugs, and even if such trials are planned, it would take a considerable amount of time to ascertain the results. However, there is a simpler method to compare the effectiveness of a new agent against existing ones, which involves evaluating the effects of switching treatment in patients who have shown limited response to the current medication. In fact, such switching to new pharmaceutical agents after their introduction is widely practiced in clinical settings.10 Historically, the excellent efficacy observed when switching from ranibizumab to aflibercept 2mg played a significant role in the widespread adoption of aflibercept 2mg.

In this study, investigators aimed to evaluate the effects of switching to aflibercept 8mg in patients who have shown limited response to previous faricimab or aflibercept 2mg treatment. To the best of our knowledge, no such study has been reported in the English literature so far. This study not only has the potential to highlight the extended duration of action of aflibercept 8mg, but also holds significant importance in addressing the current unmet needs in the treatment of neovascular AMD. Additionally, by completing the study in a short period, investigators can contribute to generating timely data that aligns with the global introduction of aflibercept 8mg.

Being tested
Aflibercept 8mg
Keywords
Age-related macular degeneration, Choroidal neovascularization, Aflibercept, Aflibercept 8mg, Faricimab, Refractory
Medical subject headings
Macular Degeneration, Choroidal Neovascularization

What participants receive

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

  • Aflibercept 8mgDrug

    Switching to intravitreal aflibercept 8mg in patients previously treated with faricimab or aflibercept 2mg.

    The dosing schedule is as follows.

    1. A single dose of 8mg aflibercept was administered to all patients
    2. After treatment 1, follow-up observations were conducted at the same intervals as previous treatments. If complete fluid resolution (no evidence of SRF or IRF) is observed, an additional dose of 8mg aflibercept is administered, extending the dosing intervals by two weeks each time.
    3. Up to three doses of 8mg aflibercept can be administered.
    4. If, after the administration of 8mg aflibercept, follow-up observations reveal remaining SRF or IRF, the study concludes without additional dosing.
Study groups in NCT06683950
Study groupRoleWhat they receive
Aflibercept 8mgExperimentalIn cases where patients previously treated with faricimab or aflibercept 2mg were switched to aflibercept 8mg
Receives: Drug: Aflibercept 8mg

What is being measured

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

  1. Presence of retinal fluid

    To access changes in retinal fluid after switching to aflibercept 8mg in patients who showed limited response to faricimab or aflibercept 2mg treatment in neovascular AMD

    Measured: Between 8 - 16 weeks (At the same interval as the previous dosing schedule for aflibercept 2mg or faricimab)

Secondary outcomes (6)

  1. Change in best-corrected visual acuity (BCVA)

    Change in best-corrected visual acuity (BCVA) after the switching to aflibercept 8mg

    Measured: Between 8 - 16 weeks (At the same interval as the previous dosing schedule for aflibercept 2mg or faricimab)

  2. Change in central retinal thickness (CRT)

    Change in central retinal thickness (CRT) after switching to aflibercept 8mg

    Measured: Between 8 - 16 weeks (At the same interval as the previous dosing schedule for aflibercept 2mg or faricimab)

  3. Change in subfoveal choroidal thickness (SCT)

    Change in subfoveal choroidal thickness (SCT) after switching to aflibercept 8mg

    Measured: Between 8 - 16 weeks (At the same interval as the previous dosing schedule for aflibercept 2mg or faricimab)

  4. Change in the size of neovascularization

    Change in the size of neovascularization as measured by OCT-A following the switching

    Measured: Between 8 - 16 weeks (At the same interval as the previous dosing schedule for aflibercept 2mg or faricimab)

  5. Maximum fluid-free period

    The longest fluid-free period (in weeks) maintained after switching to aflibercept 8mg, as assessed by optical coherence tomography images.

    Measured: Between 8 - 16 weeks (At the same interval as the previous dosing schedule for aflibercept 2mg or faricimab or 2 weeks longer or 4 weeks longer)

  6. The proportion of eyes exhibiting fluid

    The proportion of eyes exhibiting SRF, IRF, and PED

    Measured: Between 8 - 16 weeks (At the same interval as the previous dosing schedule for aflibercept 2mg or faricimab)

Timeline

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

  1. First posted12 Nov 2024
  2. Study start21 Oct 2024
  3. Primary completion14 Jul 2026
  4. Study completion14 Jul 2026

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06683950
Sponsor's protocol ID
2024-07-002
Status last verified
Jul 2026
First submitted
27 Oct 2024
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lanzetta P, Korobelnik JF, Heier JS, Leal S, Holz FG, Clark WL, Eichenbaum D, Iida T, Xiaodong S, Berliner AJ, Schulze A, Schmelter T, Schmidt-Ott U, Zhang X, Vitti R, Chu KW, Reed K, Rao R, Bhore R, Cheng Y, Sun W, Hirshberg B, Yancopoulos GD, Wong TY; PULSAR Investigators. Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial. Lancet. 2024 Mar 23;403(10432):1141-1152. doi: 10.1016/S0140-6736(24)00063-1. Epub 2024 Mar 7.

    PubMed 38461841

  • Wykoff CC, Brown DM, Reed K, Berliner AJ, Gerstenblith AT, Breazna A, Abraham P, Fein JG, Chu KW, Clark WL, Leal S, Schmelter T, Hirshberg B, Yancopoulos GD, Vitti R; CANDELA Study Investigators. Effect of High-Dose Intravitreal Aflibercept, 8 mg, in Patients With Neovascular Age-Related Macular Degeneration: The Phase 2 CANDELA Randomized Clinical Trial. JAMA Ophthalmol. 2023 Sep 1;141(9):834-842. doi: 10.1001/jamaophthalmol.2023.2421.

    PubMed 37535382

  • Raimondi R, Felfeli T, Bogdanova-Bennet A, Varma D, Habib M, Kotagiri A, Steel DH, Grinton M. Outcomes of Treatment-Resistant Neovascular Age-Related Macular Degeneration Switched from Aflibercept to Faricimab. Ophthalmol Retina. 2024 Jun;8(6):537-544. doi: 10.1016/j.oret.2023.11.015. Epub 2023 Nov 29.

    PubMed 38040055

  • Wijesingha N, Sivaprasad S. Infographic: Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE). Eye (Lond). 2024 Aug;38(Suppl 2):53-54. doi: 10.1038/s41433-023-02867-4. Epub 2023 Dec 20. No abstract available.

    PubMed 38123670

  • Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17.

    PubMed 23084240

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aflibercept 8mg in people with Age-related Macular Degeneration (ARMD), run by Kim's Eye Hospital at 1 site in South Korea.

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 9 inclusion and 20 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: finished, as of the sponsor's last update on 16 Jul 2026. 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 South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of retinal fluid (time frame: Between 8 - 16 weeks (At the same interval as the previous dosing schedule for aflibercept 2mg or faricimab)). 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 NCT06683950, which also lists 5 linked publications.

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 16 Jul 2026.

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