Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration

NCT04270669 | Completed Phase 1 DMC

• 1 other identifier: 28C001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wet Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (3)

• Mean change of BCVA from baseline at 12 week;

  Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  Baseline, Week 12

• Mean change of BCVA from baseline at 48 week;

  Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

  Baseline, Week 48

• Incidence and severity of AEs

  To evaluate the safety of multiple intravitreal injection of RC28-E of each group.）

  Baseline up to Week 48

Secondary Outcomes (3)

• The pharmacokinetic (PK) characteristics of RC28-E;

  Baseline up to Week 48

• Frequency of administration RC28-E within 48 weeks;

  Baseline up to Week 48

• Mean change of BCVA from baseline at Protocol Specified Time-Points.

  Baseline up to Week 48

Study Arms (3)

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.

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.

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.

Biological: intravitreal injection of RC28-E2.0mg

Interventions

intravitreal injection of RC28-E 0.5mg BIOLOGICAL

The patient received one treatment of RC28-E 0.5mg in the test group

RC28-E 0.5mg

intravitreal injection of RC28-E 1.0mg BIOLOGICAL

The patient received one treatment of RC28-E 1.0mg in the test group

RC28-E 1.0mg

intravitreal injection of RC28-E2.0mg BIOLOGICAL

The patient received one treatment of RC28-E 2.0mg in the test group

RC28-E 2.0mg

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• 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;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: April 15, 2020
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Locations

CN (1)