Clinical trial NCT03675880: TAB014(Drug Code) in Wet( Neovascular)Age-related Macular Degeneration(AMD) Subjects
Official title: A Phase Ⅰ Clinical Study of TAB014 in Wet( Neovascular)Age-related Macular Degeneration(AMD) Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: AMD
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects with secondary wet age-related macular degeneration(AMD) or recurrent subfoveal choroidal neovascularization (CNV) in only one study eye will be enrolled into the study.

Detailed description: The screening period was 28 days. The classification of CNV will be determined by Fundus Fluorescein Angiography ( FFA ) at the study centers. Subjects will receive intravitreal injections of TAB014 Monoclonal Antibody Injection in one eye ( the study eye ). Subjects will only receive single intravitreal dose.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects, 50 years of age or older.
2. Have secondary actively Age-related macular degeneration(wAMD) or recurrent CNV including subfoveal type and extrafoveal type in the only study eye.
3. If have occult CNV or partial classic CNV lesions will be enrolled into the study.
4. The total CNV area(both classic and occult lesion) including lesion area are more than or equal to 50% total lesion areas.
5. The total lesion area is less than or equal to 12 disk area (DA).
6. Volunteer to participate in the study and able to read and understand informed consent and provide written informed consent.

Exclusion Criteria:

1. Prior and concomitant therapy

1. Prior use of verteporfin, external beam radiation therapy or transpupillary thermotherapy(TTT) in 6 months period of the screening.
2. Subjects that have received angiogenesis inhibitors therapy, such as Pegaptanib Sodium, Lucentis, Bevacizumab, Bevacizumab (RETAANE) or protein kinase C inhibitor in either eye are participating in any other research study within the last 6 months before the screening.
3. Subjects that have received other intravitreal injection therapy(Corticosteroids or device implants) in the study eye within the last 6 months before the screening.
4. Subjects that have treated with focal argon laser photocoagulation for macular edema in study eye within the last 6 months before the screening.
5. Subjects that have undergone previous photocoagulation of the retina(extrafoveal areas) in the study eye within the last 3 months before the screening.
6. Subjects with a history of vitreoretinal surgery in the study eye.
7. Subjects that have undergone previous AMD surgery or other surgical interventions.
8. Subjects that have participated in other study of treatment with study drug(except for vitamins and minerals) within the last 3 months before the screening.

2. lesion features:

1. Area of bleeding under the retina 50% total lesion areas or 4 disk area.
2. Subfoveal fibrosis.
3. CNV that be caused by the oter reasons in either eye,such as ocular histoplasmosis syndrome, craniocerebral trauma or pathological myopia.
4. retinal pigment epithelium (RPE) tears. 3. concomitant eye disease:

1) Subjects with ongoing any concomitant eye disease(i.e cataracts or diabetic retinopathy) by the investigator's judgment:

1. Vision loss caused by these diseases to cause interference with medical or operation intervention during 3 months study.
2. Best corrected visual acuity (BCVA) loss at least of 2 lines Snellen equivalents (ETDRS 10 letters) at 3 months, if don't treat the disease.

   2) Subjects who are active endophthalmitis(with micro level or above). 3) Subjects with ongoing internal vitreous hemorrhage. 4) Subjects with Rhegmatogenous retinal detachment or history of macular holes stage 3/4.

   5) Subjects with history of idiopathic uveitis or autoimmune uveitis in either eye 6) Subjects with ongoing infectious conjunctivitis, infectious keratitis, infectious scleral or endophthalmitis in either eye.

   7) Subjects that have undergone previous intraocular surgery (including cataract surgery ) within the last 3 months before the screening.

   8) Subjects who are uncontrolled glaucoma(defined as intraocular pressure \[IOP\] 30 mmHg, even when treated with anti-glaucoma drugs).

   9) Subjects with history of glaucoma filtration surgery. 4. concomitant system disease:
   1. Subjects of child bearing ages will undergo pregnancy testing.
   2. Subjects with ongoing severe hepatic and renal disease or abnormal liver and kidney function(ALT, Angiotensin sensitivity test (AST) ≥1.5 ULN, Cr, UREA\>ULN) at Baseline.
   3. Patients with other disease history,such as uncontrolled diabetics or hypertension, periinfarction within the last 6 months,as well as not suitable for this study per the investigator's judgment.
   4. Subjects with ongoing systemic infection therapy. 5.other:

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   1. Subjects with history of fluoresceins allergy.
   2. Not get enough quality of fundus photography and fluorescein angiography used by reading and analysing from the reading center.
   3. Unwilling and not be able to return for all study visits

Primary outcomes:
measure: Toxicity associated with TAB014 treatment (possibly, probably, or definitively) occurs within 28 days after a single dose of TAB014.
timeFrame: Within 12 weeks after administration
Secondary outcomes:
measure: Dose-limiting toxicity and adverse reaction
timeFrame: Within 12 weeks after administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
name: youxin chen, PHD
role: STUDY_DIRECTOR
References:
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