Wet Age-Related Macular DegenerationPhase 1/2NCT04270669
Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration
A Phase 1/2 study testing intravitreal injection of RC28-E 0.5mg, intravitreal injection of RC28-E 1.0mg and intravitreal injection of RC28-E2.0mg in people with Wet Age-Related Macular Degeneration, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with wet age-related macular degeneration by multiple administration. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Wet Age-Related Macular Degeneration
- What is being tested?
- intravitreal injection of RC28-E 0.5mg, intravitreal injection of RC28-E 1.0mg and intravitreal injection of RC28-E2.0mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2020to 29 Oct 2021
- Phase
- Phase 1/2
- 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
- A patient must meet the following criteria to be eligible for inclusion in the study:
- Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
- Be diagnosed as wet age-related macular degeneration, choroid neovascularization (CNV) in the macular, the study eye is not treated or accepted any treatment 3 months prior to the baseline period, and still had active lesions with a diagnostic criteria according to the 2013 edition of Clinical pathway of age-related macular degeneration in China, the active CNV conforms to any item can be in the following three: New bleeding; OCT shows intraretinal fluid or subretinal fluid; Fundus angiography revealed fluorescein leakage;
- Aged 50 years to 80 years, male or female;
- BCVA ETDRS letters score of 73 to 34 in the study eye.
Who cannot join
- A patient who meets any of the following criteria will be excluded from the study:
- The study eye had vitreous hemorrhage within 2 months before screening;
- The study eye had scars or atrophy involving the fovea which indicating severe irreversible visual impairment;
- The study eye had significant refractive media opacity, including cataract, may interfere with visual assessment;;
- The study eye had 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 wAMD (such as vascular striation, ocular histoplasmosis, pathological myopia, trauma, etc.);
- The study eye had subretinal or intra-retinal bleeding with bleeding area ≥ 50% of the total lesion area, or subfoveal bleeding with bleeding area was ≥4 optic disc areas;
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- The study eye had significant afferent pupillary defect;
- The study eye was aphakia (excluding artificial lens);
- The study eye was treated with local/grid laser photocoagulation in macular within 3 months prior to baseline;
- The study eye had received the following intraocular surgery or laser treatment in macular (such as macular transposition, glaucoma filtrating surgery, transpupillary thermotherapy, vitrectomy, optic neurotomy, etc.); However, subjects which had received verteporfin-photodynamic therapy, cataract surgery, and neodymium yttrium aluminum garnet (YAG) capsulotomy in the study eye more than 3 months prior to baseline is eligible for inclusion;
- Intraocular pressure in the study eye was≥25mmHg despite medication treatment;
- Either eye had active ocular infection/inflammation during the screening period, such as conjunctivitis, keratitis, scleritis, blepharitis, endophthalmitis and uveitis;
- The visual acuity of any eye is less than 19 letters (by ETDRS chart);
- Either eye or systemic had received anti-angiogenic therapy within 3 months prior to baseline visit (e.g. aflibercept, ranibizumab, conbercept, etc.);
- Either eye that received IVT corticosteroids (e.g. triamcinolone acetonide, dexamethasone) within 6 months prior to baseline visit or received periocular injection of corticosteroids within 1 month prior to screening;
- Allergy to sodium fluorescein, indocyanine green, therapeutic or diagnostic protein products, and allergic ≥2 drugs and/or non-drug factors;
- Uncontrolled diabetes mellitus (HbA1c ≥7%) and/or diabetic patients with diabetic retinopathy;
- Uncontrolled hypertension (defined as those who received the best treatment regimen, > 180mmHg systolic was measured once, > 160mmHg systolic or > 100mmHg diastolic was measured twice in succession);
- History of cardiovascular and cerebrovascular events within 6 months of screening visit: myocardial infarction, unstable angina pectoris, ventricular arrhythmias, New York heart association grade II + heart failure, stroke, etc.;
- History of surgery within 1 month before screening, or have unhealed wounds, fractures, etc.;
- Uncontrolled clinical disease (such as malignant tumors, severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases);
- Platelets count ≤100×10^9/L, thrombin time and prothrombin time exceeding more than 3 second above the upper limit of the normal range (The normal range of the clinical trial institution was taken as the standard); with active disseminated intravascular coagulation or significant bleeding tendency prior to screening; using anticoagulants or antiplatelet aggregation drugs in addition to aspirin/NASIDs within 14 days before screening;
- Pregnant or lactating women. Subjects of child-bearing age (male and female) do not agree to use effective contraception (such as intrauterine devices, acyeterion or condoms) throughout the study period and 30 days after the end of the visit;
- Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before the baseline period;
- Those who considered unsuitable for enrollment by investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nonrandomized, Open-label Study to Evaluate the Safety and Pharmacokinetics of Multiple Administration of RC28-E Injection (a Chimeric Decoy Receptor Trap Fusion Protein by Dual Blockage of VEGF and FGF-2) in Subjects With Wet Age-Related Macular Degeneration
This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with wet age-related macular degeneration by multiple administration.
- Conditions
- Wet Age-Related Macular Degeneration
- Being tested
- intravitreal injection of RC28-E 0.5mg, intravitreal injection of RC28-E 1.0mg, intravitreal injection of RC28-E2.0mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection of RC28-E 0.5mgBiological
The patient received one treatment of RC28-E 0.5mg in the test group
intravitreal injection of RC28-E 1.0mgBiological
The patient received one treatment of RC28-E 1.0mg in the test group
intravitreal injection of RC28-E2.0mgBiological
The patient received one treatment of RC28-E 2.0mg in the test group
| Study group | Role | What they receive |
|---|---|---|
| RC28-E 0.5mg | Experimental | In the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 0.5mg RC28-E every 4 weeks, for 3 consecutive times; In the PRN phase (from week 12 to week 48), the study eye will receive the same dose on an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. Receives: Biological: intravitreal injection of RC28-E 0.5mg |
| RC28-E 1.0mg | Experimental | In the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 1.0 mg RC28-E every 4 weeks, for 3 consecutive times; In the PRN phase (from week 12 to week 48), the study eye will receive the same dose on an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. Receives: Biological: intravitreal injection of RC28-E 1.0mg |
| RC28-E 2.0mg | Experimental | In the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 2.0 mg RC28-E every 4 weeks, for 3 consecutive times; In the PRN phase (from week 12 to week 48), the study eye will receive the same dose on an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. Receives: Biological: intravitreal injection of RC28-E2.0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of BCVA from baseline at 12 week;
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Measured: Baseline, Week 12
Mean change of BCVA from baseline at 48 week;
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Measured: Baseline, Week 48
Incidence and severity of AEs
To evaluate the safety of multiple intravitreal injection of RC28-E of each group.）
Measured: Baseline up to Week 48
Secondary outcomes (3)
The pharmacokinetic (PK) characteristics of RC28-E;
Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.
Measured: Baseline up to Week 48
Frequency of administration RC28-E within 48 weeks;
Number of intravitreal injections
Measured: Baseline up to Week 48
Mean change of BCVA from baseline at Protocol Specified Time-Points.
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Measured: Baseline up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start15 Apr 2020
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04270669
- Sponsor's protocol ID
- 28C001
- Status last verified
- Jan 2022
- First submitted
- 12 Feb 2020
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nonrandomized, Open-label Study to Evaluate the Safety and Pharmacokinetics of Multiple Administration of RC28-E Injection (a Chimeric Decoy Receptor Trap Fusion Protein by Dual Blockage of VEGF and FGF-2) in Subjects With Wet Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT04270669
- Acronym / sponsor ID
- 28C001
- Conditions
- Wet Age-Related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with wet age-related macular degeneration by multiple administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RC28-E 0.5mg | Experimental | Biological: intravitreal injection of RC28-E 0.5mgIn the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 0.5mg RC28-E every 4 weeks, for 3 consecutive times; In the PRN phase (from week 12 to week 48), the study eye will receive the same dose on an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. |
| RC28-E 1.0mg | Experimental | Biological: intravitreal injection of RC28-E 1.0mgIn the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 1.0 mg RC28-E every 4 weeks, for 3 consecutive times; In the PRN phase (from week 12 to week 48), the study eye will receive the same dose on an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. |
| RC28-E 2.0mg | Experimental | Biological: intravitreal injection of RC28-E2.0mgIn the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 2.0 mg RC28-E every 4 weeks, for 3 consecutive times; In the PRN phase (from week 12 to week 48), the study eye will receive the same dose on an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
- Be diagnosed as wet age-related macular degeneration, choroid neovascularization (CNV) in the macular, the study eye is not treated or accepted any treatment 3 months prior to the baseline period, and still had active lesions with a diagnostic criteria according to the 2013 edition of Clinical pathway of age-related macular degeneration in China, the active CNV conforms to any item can be in the following three: New bleeding; OCT shows intraretinal fluid or subretinal fluid; Fundus angiography revealed fluorescein leakage;
- Aged 50 years to 80 years, male or female;
- BCVA ETDRS letters score of 73 to 34 in the study eye.
Key exclusion criteria (25 listed)
- The study eye had vitreous hemorrhage within 2 months before screening;
- The study eye had scars or atrophy involving the fovea which indicating severe irreversible visual impairment;
- The study eye had significant refractive media opacity, including cataract, may interfere with visual assessment;;
- The study eye had 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 wAMD (such as vascular striation, ocular histoplasmosis, pathological myopia, trauma, etc.);
- The study eye had subretinal or intra-retinal bleeding with bleeding area ≥ 50% of the total lesion area, or subfoveal bleeding with bleeding area was ≥4 optic disc areas;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravitreal injection of RC28-E 0.5mgThe patient received one treatment of RC28-E 0.5mg in the test group | Biological | RC28-E 0.5mg |
| intravitreal injection of RC28-E 1.0mgThe patient received one treatment of RC28-E 1.0mg in the test group | Biological | RC28-E 1.0mg |
| intravitreal injection of RC28-E2.0mgThe patient received one treatment of RC28-E 2.0mg in the test group | Biological | RC28-E 2.0mg |
Primary outcome
Mean change of BCVA from baseline at 12 week;
Time frame: Baseline, Week 12
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Mean change of BCVA from baseline at 48 week;
Time frame: Baseline, Week 48
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Incidence and severity of AEs
Time frame: Baseline up to Week 48
To evaluate the safety of multiple intravitreal injection of RC28-E of each group.）
3 secondary outcomes
The pharmacokinetic (PK) characteristics of RC28-E;
Time frame: Baseline up to Week 48
Frequency of administration RC28-E within 48 weeks;
Time frame: Baseline up to Week 48
Mean change of BCVA from baseline at Protocol Specified Time-Points.
Time frame: Baseline up to Week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing intravitreal injection of RC28-E 0.5mg, intravitreal injection of RC28-E 1.0mg and intravitreal injection of RC28-E2.0mg in people with Wet 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 25 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 10 Jan 2022. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean change of BCVA from baseline at 12 week; (time frame: Baseline, Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2022.