A Phase 3 study of HLX04-O efficacy and safety, administered in to the eye by injection, with Ranibizumab in subjects with wet Age related Macular Degeneratio
- Conditions
- Wet Age-related Macular Degeneration (wAMD)MedDRA version: 20.0Level: LLTClassification code 10075568Term: Wet age-related macular degenerationSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2020-005364-57-CZ
- Lead Sponsor
- Shanghai Henlius Biotech. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 388
1. Capable to understand, and sign the informed consent form (ICF)
which includes compliance with the requirements and restrictions.
2. Women or men aged =50 years when signing the ICF.
3. In the Investigator's judgment, willing and able to complete all visits
and assessments adhering to the prohibitions and restrictions specified
in the protocol.
4. Newly diagnosed, untreated, active subfoveal or juxtafoyeal CNV
lesions secondary to age-related macular degeneration in the study eye.
Active CNV was defined as leakage on fluorescein angiography (FA) and
subretinal or intraretinal fluid on optical coherence tomography (OCT)
with confirmation of the reading center during screening.
5. The total lesion area (including hemorrhage, scar and
neovascularization) of the study eye =12 disc area (DA) with
confirmation of the reading center before randomization.
6. The BCVA letters between 24 and 73, inclusive, in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
7. Participants' fellow (non-study) eyes must have had a BCVA of 24 letters or better.
8. Clear ocular media and adequate pupillary dilatation to allow
acquisition of good quality retinal images to confirm the diagnosis.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 374
1.Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis or atrophy involving the fovea, or CNV due to other causes in the study eye with confirmation of the reading center.
2.The fellow (non study) eye needs anti-VEGF IVT injection in the next 3 months after randomization, in the investigator's judgment.
3.Aphakia (except intraocular lens) or posterior capsular rupture of the lens (except yttrium aluminium-garnet (YAG) laser posterior
capsulotomy after intraocular lens implantation =30 days prior to first dose) in the study eye.
4.Active or recent (within 1 month prior to dose 1) intraocular,
extraocular or periocular infection (including conjunctivitis, keratitis, scleritis or endophthalmitis), or history of idiopathic or
autoimmuneassociated uveitis in either eye.
5.Vitreous hemorrhage in the study eye within 3 months prior to dose 1.
6.Corneal dystrophy or history of corneal transplantation, scleral
softening or history of scleral softening, history of rhegmatogenous
retinal detachment or macular hole (Stage II, III or IV) in the study eye.
7.Uncontrolled glaucoma in the study eye (defined as intraocular
pressure [IOP] =25 mmHg despite treatment with antiglaucoma
medication), and/or glaucoma filtering surgery
8.Equivalent spherical diopter of the study eye =-8D.
9.Estimated by the Investigator, any concurrent intraocular condition except wAMD in the study eye that limited the potential to gain visual acuity upon treatment with the investigational product, or could have required medical or surgical intervention during the study to prevent or treat visual loss.
10.Underwent intraocular surgery including verteporfin photodynamic therapy (PDT), transpupillary thermotherapy, macular translocation, vitrectomy, laser photocoagulation in macular area, other surgery in macular area or surgery to treat AMD.
11.Previous extraocular or periocular surgery within 1 month or
intraocular surgery (including cataract surgery, etc.) within 3 months prior to dose 1, or current unhealed wound, moderate or severe ulcer or fracture in the study eye.
12.Subconjunctival or intraocular or systemic use of corticosteroids
within 3 months prior to dose 1 in the study eye.
13.Previous systemic anti-VEGF therapy or IVT injection of any anti-
VEGF drug into either eye or other ocular use of anti-VEGF drug within 3 months prior to dose 1.
14.Participated in any drug (other than vitamins and minerals) or device clinical trials 3 months or the duration of 5 half-lives of the study drug (which is longer) before the first dose and have used the test drug or received device treatment.
15.Pregnancy or lactation, or fertile men or women not willing to use effective contraception from the day when ICF was signed to at least 6 months following the last dose of study intervention.
16.Infertile women or men fail to meet either of the following ones: 1) menopause 2) surgically sterilized.
Fertile women or men fail to meet either of the following ones: 1)
women of childbearing potential must have a negative urine or serum pregnancy test result within 14 days prior to initiation of the study intervention and should not breastfeed. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test; 2) agreement to remain abstinent (refrain from heterosexual intercourse) or use effective contraceptive methods from signed ICF to at least 6 months following the last dose of study intervention.
17.In the Investigator's judgment, there
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of HLX04-O at Week 36 compared with<br>ranibizumab in patient's study eye with wAMD.<br>;Secondary Objective: To evaluate the efficacy of HLX04-O at Week 12, 24, 36 and 48 compared with ranibizumab in patient's study eye with wAMD.<br>To evaluate the safety and tolerability of HLX04-O compared with<br>ranibizumab in patients with wAMD.<br>To characterize the systemic pharmacokinetics of HLX04-O IVT<br>administration.;Primary end point(s): Mean change from baseline in best-corrected visual acuity (BCVA) at<br>Week 36.;Timepoint(s) of evaluation of this end point: Week 36
- Secondary Outcome Measures
Name Time Method