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Neovascular(Wet) Age Related Macular DegenerationPhase 3NCT04857177

A Study To Evaluate CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration

A Phase 3 study testing CKD-701 and Lucentis® in people with Neovascular(Wet) Age Related Macular Degeneration, run by Chong Kun Dang Pharmaceutical 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
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Trial summary

This is a multicenter, randomized, double-blind, active-controlled, parallel group, Phase III Clinical Trial To Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of CKD-701 and Lucentis® in Patients with Neovascular(wet) Age related Macular Degeneration Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
CKD-701 and Lucentis®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
1 siteSouth Korea
Study dates
19 Oct 2018to 17 Mar 2021
Phase
Phase 3
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
  • Presence in the study eye of active subfoveal CNV lesion due to AMD
  • The total lesion size ≤ 12 DA in the study eye
  • The presence of CNV foci of more than 50% of the total lesion area in the study eye
  • The best-corrected visual acuity within a range from 78 to 34 letters (20/32~20/200) measured using the ETDRS chart in the study eye
  • Written informed consent

Who cannot join

  • Any previous anti-vascular endothelial growth factor(anti-VEGF) treatment to treat neovascular AMD
  • Presence of eye-related inflammation or infection, such as Infectious ophthalmitis, corneal inflammation, conjunctivitis (including scleromalacia), endocular inflammation
  • Any history or clinical basis of disease affecting the retina except age-related macular degeneration(AMD), such as diabetic retinopathy, diabetic macular edema
  • Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, angioid streaks retinopathy or pathologic myopia
  • Patients with macular abnormalities other than age-related macular degeneration (AMD)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, Phase III Clinical Trial To Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of CKD-701 and Lucentis® in Patients With Neovascular(Wet) Age Related Macular Degeneration

This is a multicenter, randomized, double-blind, active-controlled, parallel group, Phase III Clinical Trial To Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of CKD-701 and Lucentis® in Patients with Neovascular(wet) Age related Macular Degeneration

Read the detailed description

Subjects will be randomised in a 1:1 ratio to receive either CKD-701 or Lucentis®. Investigational Products (IP) (CKD-701 or Lucentis®) will be administered once a month during the loading phase(the first three months), and for the next nine months(PRN phase), administion will be determined based on the PRN administration criteria.

Being tested
CKD-701, Lucentis®
Keywords
Neovascular(wet) Age related Macular Degeneration, CKD-701
Medical subject headings
Macular Degeneration

What participants receive

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

  • CKD-701Drug

    CKD-701 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every one month during the loading phase, and intervals of one month based on criteria during the PRN phase.

  • Lucentis®Drug

    Lucentis® (ranibizumab) 0.5mg via intravitreal injection every one month during the loading phase, and intervals of one month based on criteria during the PRN phase.

Study groups in NCT04857177
Study groupRoleWhat they receive
CKD-701ExperimentalDrug: CKD-701 (proposed ranibizumab biosimilar)
Receives: Drug: CKD-701
Lucentis®Active comparatorDrug: Lucentis® (ranibizumab)
Receives: Drug: Lucentis®

What is being measured

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

  1. The proportion of patients with a decrease in the best-corrected visual acuity (BCVA) score of 15 or fewer letters at 3 months versus baseline.

    Measured: Baseline to 3 months

Secondary outcomes (5)

  1. Mean change in the best-corrected visual acuity (BCVA) score from baseline to 3 months, 6 months and 12 months

    Measured: Baseline, 3 months, 6 months, 12 months

  2. The proportion of patients with a decrease in the best-corrected visual acuity (BCVA) score of 15 or fewer letters at 6 months, 12 months versus baseline

    Measured: Baseline, 6 months, 12 months

  3. The proportion of patients with an increase in the best-corrected visual acuity (BCVA) score of 15 or more letters at 3 months, 6 months, 12months versus baseline

    Measured: Baseline, 3 months, 6 months, 12 months

  4. Change in the Central Retinal Thickness(CRT) at 1 months, 3 months, 6 months, 12months versus baseline

    Measured: Baseline, 1 months, 3 months, 6 months, 12 months

  5. The proportion of patients with the absence of intraretinal fluid and subretinal fluid at 3 months, 6 months, 12months versus baseline

    Measured: 3 months, 6 months, 12 months

Timeline

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

  1. First posted23 Apr 2021
  2. Study start19 Oct 2018
  3. Primary completion17 Mar 2021
  4. Study completion17 Mar 2021

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04857177
Sponsor's protocol ID
177AMD17019
Status last verified
Apr 2021
First submitted
21 Apr 2021
Last updated
23 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CKD-701 and Lucentis® in people with Neovascular(Wet) Age Related Macular Degeneration, run by Chong Kun Dang Pharmaceutical 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 6 inclusion and 5 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 23 Apr 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The proportion of patients with a decrease in the best-corrected visual acuity (BCVA) score of 15 or fewer letters at 3 months versus baseline. (time frame: Baseline to 3 months). 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 NCT04857177.

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 23 Apr 2021.

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