Evaluation of RC28-E Injection in Diabetic Retinopathy

RemeGen

Status and phase

Active, not recruiting

Phase 2

Conditions

Diabetic Retinopathy

Treatments

Biological: RC28-E injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT04782128

28C003

Details and patient eligibility

About

This is a randomized, open-label, multicenter study of the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in the treatment of patients with moderately severe to severe nonproliferative diabetic retinopathy.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
Aged 18 years to 80 years, male or female;
Diabetes mellitus(type 1 or 2);
Moderately severe to severe NPDR (DRSS levels 47 or 53) which was confirmed by the central reading center, and in whom PRP can be safely deferred by the investigator's judgement;
BCVA score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) using the ETDRS protocol at an initial testing distance of 4 meters;
If both eyes meet the inclusion criterion, one eye with poor BCVA is selected as the study eye;

Exclusion criteria

Presence of DME threatening the center of the macula (within 1,000 microns of the foveal center) in the study eye;
Evidence of retinal neovascularization on clinical examination or FA;
Any prior focal or grid laser photocoagulation (within 1,000 microns of the foveal center) or PRP in the study eye;
Current ASNV, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involved the macular in the study eye;
History of vitreoretinal surgery in the study eye;
Active infectious blepharitis, keratitis, scleritis, conjunctivitis at the screening assessments in either eye ;
Previous treatment with anti-angiogenic drugs in either eye or system (ranibizumab, aflibercept, conbercept, etc) within 3 months of the Day 0 visit;
Previous use of intraocular or periocular corticosteroids (such as triamcinolone acetonide, dexamethasone vitreous implant) in either eye within 6 months of day 0.
Uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors;
Pregnant or lactating women, subjects who had family planning throughout the study period;
Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before theDay 0
Those who considered unsuitable for enrollment by investigator.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 4 patient groups

intravitreal 1.0mg RC28-E injection Q8

Experimental group

Description:

Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.

Treatment:

Biological: RC28-E injection

Experimental: intravitreal 1.0mg RC28-E injection PRN

Experimental group

Description:

Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 5 visits followed by injections an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria.

Treatment:

Biological: RC28-E injection

Experimental: intravitreal 2.0mg RC28-E injection Q8

Experimental group

Description:

Subjects received 2.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.

Treatment:

Biological: RC28-E injection

Experimental: intravitreal 2.0mg RC28-E injection PRN

Experimental group

Description:

Treatment: