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Neovascular Age-related Macular DegenerationPhase 1NCT03777254

Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration

A Phase 1 study testing RC28-E in people with Neovascular Age-related Macular Degeneration, run by RemeGen Co., Ltd. at 1 site in China.

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

The purpose of this first-in-human study is to evaluate the safety, tolerability and pharmacokinetics of single intravitreous injections,single ascending doses, of RC28-E(a chimeric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in subjects with wet age-related macular degeneration (wAMD). Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
RC28-E
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
7 Jan 2019to 20 Aug 2019
Phase
Phase 1
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients or their legal representative signed informed consent;
  • Aged 50 years to 80 years, male or female;
  • Best corrected VA for the studied eye≥34 letters, ≤73 letters(By ETDRS chart);
  • With choroidal neovascular (CNV) lesions secondary to neovascular AMD;
  • If both eyes meet the criteria, severe illness eye will be selected; if both eyes are the same, the right eye will be selected as the study eye.

Who cannot join

  • History of any vitreous hemorrhage with 2 months prior to screening;
  • Presence of scar, fibrosis or atrophy in central foveal of the study eye;
  • Significant refractive media opacity, including cataract, may interfere with visual assessment;
  • The studied eye suffered pseudoexfoliation syndrome, central retinal vein occlusion, intraocular hemorrhage resulting in decreased vision, rhegmatogenous retinal detachment, macular hole, choroidal neovascularization (CNV) for any reason other than AMD (such as fundus angioid streaks, ocular histoplasmosis, pathologic myopia, trauma);
  • Afferent pupillary defect(APD);
  • The intraocular pressure is higher than 25mmHg despite medication treatment;
Show all 23Show fewer
  • Active infectious conjunctivitis, keratitis, scleritis, uveitis and endophthalmitis;
  • Best corrected VA for the studied eye≤19 letters(By ETDRS chart);
  • Topical or grid photocoagulation within 3 months before screening;
  • Uncontrolled diabetes mellitus(fast glucose level≥7.0 mmol/L or ≥11.1 mmol/L 2h after meal;
  • The studied eye received any intraocular surgery or laser treatment (such as macular translocation surgery, glaucoma filtering surgery, transpupillary thermotherapy, foveal photocoagulation surgery, vitrectomy, optic neurotomy, optic nerve sheath fenestration; But cataract surgery, verteporfin photodynamic therapy, Nd:YAG laser posterior capsulotomy more than 3 months before screening can be selected;
  • Any eye or whole body received anti-angiogenic drug such as pegaptanib, Aflibercept, Ranibizumab, Bevacizumab,conbercept within 3 months before baseline visit;
  • Any eye received intraocular injection of corticosteroid drugs (such as triamcinolone acetonide) within 3 months before screening, or periocular injection of corticosteroid drugs within 1 months before screening;
  • Allergic to sodium fluorescein, indocyanine green, therapeutic or diagnostic protein products, and allergic ≥2 drugs and/or non-drugs, or with current allergic diseases;
  • With surgery within one month prior to enrollment, or with unhealed wound, ulcer, fracture at present;
  • No lens (excluding intraocular lens);
  • Uncontrolled hypertension(defined as those who received the best treatment regimen, >180 mmHg systolic was measured once, >160 mmHg systolic or > 100 mmHg diastolic was measured twice in succession);
  • With a history of myocardial infarction within 6 months before screening;
  • With activity disseminated intravascular coagulation and significant bleeding tendency prior to screening; Using anticoagulants or antiplatelet aggregation drugs in addition to aspirin/NSAIDs within 14 days before screening;
  • Any uncontrolled clinical disease (such as severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
  • Pregnant (blood pregnancy test positive) and lactating women and patients who cannot take effective contraception(such as intrauterine devices, acyeterion, condoms, etc.) between study period or 30 days after visit;
  • Patients who participated in or were currently attending other clinical studies within 30 days before screening;
  • The patients is considered unsuitable for enrollment by investigator. "

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tongren Hospital .Cmu

    Beijing, 100730

Other trials in China

About this study

Official title: A Double-center, Open-label,Single Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravitreous Injections of RC28-E (a Chimeric Decoy Receptor Trap Fusion Protein by Dual Blockage of VEGF and FGF-2) in Subjects With Wet Age-Related Macular Degeneration

The purpose of this first-in-human study is to evaluate the safety, tolerability and pharmacokinetics of single intravitreous injections,single ascending doses, of RC28-E(a chimeric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in subjects with wet age-related macular degeneration (wAMD).

Read the detailed description

This is an open-label, non-randomized,double-center phase 1 study evaluating pharmacokinetics, safety and tolerability of single intravitreal injections of RC28-E in the patients with AMD.RC28-E is recombinant dual decoy receptor IgG1 Fc-fusion protein,can block VEGF-A and FGF-2. In preclinical studies suggested that RC28-E might be more effective in inhibiting pathological angiogenesis than other VEGF antagonists on CNV. Every subject will only accept one dose. In addition to safety and preliminary efficacy, pharmacokinetics and immunogenicity of RC28-E will be evaluated as well.

Being tested
RC28-E

What participants receive

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

  • RC28-EBiological

    Also called RC28-E is a chimeric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2.

    RC28-E intravitreous injection 50ul

Study groups in NCT03777254
Study groupRoleWhat they receive
RC28-EExperimental"·Experimental:RC28-E 0.25mg Injection:single Intravitreal Injection Intervention: Biological: RC28-E * Experimental: RC28-E 0.5mg Injection:single Intravitreal Injection Intervention: Biological: RC28-E * Experimental: RC28-E 1.0mg Injection:single Intravitreal Injection Intervention: Biological: RC28-E * Experimental: RC28-E 2.0mg Injection:single Intravitreal Injection Intervention: Biological: RC28-E"
Receives: Biological: RC28-E

What is being measured

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

  1. Incidence of ocular and systemic adverse events and serious adverse events which are related to RC28-E

    Measured: 42 days

Secondary outcomes (6)

  1. Area under the plasma concentration-time curve(AUC)

    Measured: 42 days

  2. Maximum observed maximum plasma concentration (Cmax)

    Measured: 42 days

  3. Time to reach the maximum observed plasma concentration (Tmax)

    Measured: 42 days

  4. T1/2(Terminal phase half life after single dose)

    Measured: 42 days

  5. Change in Best Corrected Visual Acuity (BCVA) from baseline

    Measured: 42 days

  6. Change in Central Retinal Thickness（CRT）from baseline

    Measured: 42 days

Timeline

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

  1. First posted17 Dec 2018
  2. Study start7 Jan 2019
  3. Primary completion20 Aug 2019
  4. Study completion20 Aug 2019

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777254
Sponsor's protocol ID
C001AMDCLLI
Status last verified
Apr 2021
First submitted
9 Dec 2018
Last updated
27 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kou X, Sun Y, Li S, Bian W, Liu Z, Zhang D, Jiang J. Pharmacology Study of the Multiple Angiogenesis Inhibitor RC28-E on Anti-Fibrosis in a Chemically Induced Lung Injury Model. Biomolecules. 2019 Oct 24;9(11):644. doi: 10.3390/biom9110644.

    PubMed 31652997

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RC28-E in people with Neovascular Age-related Macular Degeneration, run by RemeGen Co., Ltd. at 1 site in China.

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 5 inclusion and 23 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 27 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Incidence of ocular and systemic adverse events and serious adverse events which are related to RC28-E (time frame: 42 days). 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 NCT03777254, 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 27 Apr 2021.

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