TAB014(Drug Code) in Wet( Neovascular)Age-related Macular Degeneration(AMD) Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1.25mg(0.05ml) single-dose Eight subjects will be treated with TAB014 1.25mg(0.05ml) single-dose |
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
|
| Experimental: 2.00mg(0.08ml) single-dose Eight subjects will be treated with TAB014 2.00mg(0.08ml) single-dose |
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
|
| Experimental: 2.50mg(0.10ml) single-dose Eight subjects will be treated with TAB014 2.50mg(0.10ml) single-dose |
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
|
| Experimental: 1.25mg(0.05ml) multiple-dose Eight subjects will be treated with TAB014 1.25mg(0.05ml) multiple-dose after 1.25mg(0.05ml) single-dose |
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
|
| Experimental: 2.00mg(0.08ml) multiple-dose Eight subjects will be treated with TAB014 2.00mg(0.08ml) multiple-dose after 2.00mg(0.08ml) single-dose |
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
|
| Experimental: 2.50mg(0.10ml) multiple-dose Eight subjects will be treated with TAB014 2.50mg(0.10ml) multiple-dose after 2.50mg(0.10ml) single-dose |
Drug: TAB014
TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Toxicity associated with TAB014 treatment (possibly, probably, or definitively) occurs within 28 days after a single dose of TAB014. [Within 12 weeks after administration]
Describe the impairment of vision by examination.
Secondary Outcome Measures
- Dose-limiting toxicity and adverse reaction [Within 12 weeks after administration]
To Assess the dose-limiting toxicity and adverse reaction of TAB014 Monoclonal Antibody Injection.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female subjects, 50 years of age or older.
-
Have secondary actively Age-related macular degeneration(wAMD) or recurrent CNV including subfoveal type and extrafoveal type in the only study eye.
-
If have occult CNV or partial classic CNV lesions will be enrolled into the study.
-
The total CNV area(both classic and occult lesion) including lesion area are more than or equal to 50% total lesion areas.
-
The total lesion area is less than or equal to 12 disk area (DA).
-
Volunteer to participate in the study and able to read and understand informed consent and provide written informed consent.
Exclusion Criteria:
-
Prior and concomitant therapy
-
Prior use of verteporfin, external beam radiation therapy or transpupillary thermotherapy(TTT) in 6 months period of the screening.
-
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.
-
Subjects that have received other intravitreal injection therapy(Corticosteroids or device implants) in the study eye within the last 6 months before the screening.
-
Subjects that have treated with focal argon laser photocoagulation for macular edema in study eye within the last 6 months before the screening.
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Subjects that have undergone previous photocoagulation of the retina(extrafoveal areas) in the study eye within the last 3 months before the screening.
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Subjects with a history of vitreoretinal surgery in the study eye.
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Subjects that have undergone previous AMD surgery or other surgical interventions.
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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.
-
lesion features:
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Area of bleeding under the retina 50% total lesion areas or 4 disk area.
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Subfoveal fibrosis.
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CNV that be caused by the oter reasons in either eye,such as ocular histoplasmosis syndrome, craniocerebral trauma or pathological myopia.
-
retinal pigment epithelium (RPE) tears. 3. concomitant eye disease:
- Subjects with ongoing any concomitant eye disease(i.e cataracts or diabetic retinopathy) by the investigator's judgment:
-
Vision loss caused by these diseases to cause interference with medical or operation intervention during 3 months study.
-
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.
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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.
-
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.
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Subjects that have undergone previous intraocular surgery (including cataract surgery ) within the last 3 months before the screening.
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Subjects who are uncontrolled glaucoma(defined as intraocular pressure [IOP] 30 mmHg, even when treated with anti-glaucoma drugs).
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Subjects with history of glaucoma filtration surgery. 4. concomitant system disease:
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Subjects of child bearing ages will undergo pregnancy testing.
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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.
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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.
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Subjects with ongoing systemic infection therapy. 5.other:
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Subjects with history of fluoresceins allergy.
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Not get enough quality of fundus photography and fluorescein angiography used by reading and analysing from the reading center.
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Unwilling and not be able to return for all study visits
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital of Chinese Academy of Medical Sciences | Beijing | Beijing | China | 100032 |
Sponsors and Collaborators
- Lee's Pharmaceutical Limited
Investigators
- Study Director: youxin chen, PHD, Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZK-TAB-201709