Clinical trial registry record

Evaluation the Pharmacokinetics, Safety, Tolerability of BCD-021 in Patients With Neovascular Age-related Macular Degeneration

A registered PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Withdrawn. Registration does not establish safety or effectiveness.

Plain-language guide

Five questions to ask about this record

What this is
A clinical study registration, not a result or recommendation.
Why it may matter
The registry currently reports Withdrawn.
Evidence
Registered phase 1 study.
Main limitation
Registration does not prove that the intervention works, is safe, or is available to you.
What changed
Registry metadata was last updated March 31, 2016.
Where to verify
Open the primary registry below for eligibility, locations, contacts, and current status.
Registry ID
NCT02450981
Last registry update
March 31, 2016
Status
Withdrawn
Phase
Phase 1
Sponsor
Biocad
Enrollment
0
Match confidence
100%
Source feed
ClinicalTrials.gov
Automated source synopsis

A registered PHASE1 study indexed because it matched monitored longevity research terms. Registry status: Withdrawn. Registration does not establish safety or effectiveness.

Evidence snapshot

What the source actually supports

Evidence stage
Phase 1
Study design
NA · SINGLE GROUP · NONE
Evidence population
Human clinical study registration
Participants
0
Population
ALL · 50 Years
Duration
Not reported
Intervention
Bevacizumab (BCD-021)
Comparator
Not reported
Outcomes measured
Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to BCD-021 an…; Frequency of ocular and systemic AEs and SAEs related to age-related macular degeneration (AMD) therapy, appeared withi…; Number of cases of early withdrawal from the study caused by AE or SAE — 12 months; Area under the plasma concentration-time curve from zero (0) hours to 28 days, maximum concentration and half life of b…; Area under the plasma concentration-time curve from 56 days to 84 days, maximum concentration and half life of bevacizu…; Minimum concentration of bevacizumab between the first and the third administration of BCD-021 — 28 days; Number of patients who have binding and neutralizing antibodies to BCD-021 in serum at screening, after 3 intravitreal…; Mean change in visual acuity score, measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale at month 1…; Change in fluid and foveal thickness on OCT during the study — 12 months; Timing of visual improvement after initiation of therapy — 12 months
Reported result
No reusable finding-level result is available in this record.

Main limitationThis is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.

Safety and approvalEligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians. Trial registration is not regulatory approval and does not establish that an intervention is available.

Source supportStructured registry protocol metadata; no finding-level conclusion is generated.

Trial stage · Phase 1A trial phase describes development stage; it does not establish a positive result.
Phase 1Phase 2Phase 3Phase 4

Registration and recruitment status do not establish safety, efficacy, or regulatory approval.

Why this record appears here · 100% topic match

The title, summary, or source keywords matched one or more topics followed by immortal.life. A higher percentage means a stronger topic match; it does not rate safety, effectiveness, or study quality.

  • Vision ageing · 100%Title contains controlled topic terminology. Summary contains controlled topic terminology. Source terminology contains a controlled topic term. Title supplies ageing or longevity context.

Automated source check 100% · update recency 35%. These figures help sort records; they are not medical ratings.

vision aging
Read the original source →Export JSON