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An Open, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration (wAMD)

An Open, Non-randomize, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02098720
Acronym
LAMP
Enrollment
30
Registered
2014-03-28
Start date
2011-12-31
Completion date
Unknown
Last updated
2014-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Low Vision Secondary to Wet Age-related Macular Degeneration

Brief summary

This study is designed to evaluate the effect of Conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration.

Interventions

Sponsors

Chengdu Kanghong Biotech Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients give fully informed consent and are willing and able to comply with all study procedures. 2. In the study eye: There are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (CNV) lesions secondary to wAMD. The criterion of active CNV should meet at least one of following three conditions : * fresh bleeding; * neurosensory detachment showed on optical coherence tomography(OCT); * leakage showed on fundus fluorescein angiography (FFA). 3. BCVA in study eye \< 19 letters (approximately 20/400 Snellen equivalent).

Exclusion criteria

1. Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision; 2. Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas; 3. History of vitreous hemorrhage within last month; 4. The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye; 5. Photodynamic therapy (PDT) or drug treatment of CNV within last 6 months in study eye, or anti-vascular endothelial growth factor (VEGF) therapy in fellow eye within last month; 6. History of glaucoma in study eye; 7. Aphakia (excluding artificial lens) in the study eye.

Design outcomes

Primary

MeasureTime frame
percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain6-month

Secondary

MeasureTime frameDescription
mean change in BCVA from baseline6-month
change from baseline of macular area thickness and other anatomy results6-month
safety of Conbercept therapy6-monthTo assess incidence of adverse events, incidence of adverse drug reactions etc.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026