Clinical trial registry record

Safety and Efficacy Study of BCD-021 Compared to Lucentis® in Patients With Neovascular Wet Age-related Macular Degeneration

A registered PHASE3 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 Registry status: Withdrawn.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The registry currently reports Withdrawn.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 3 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
NCT02036723
Last registry update
March 31, 2016
Status
Withdrawn
Phase
Phase 3
Sponsor
Biocad
Enrollment
0
Countries
Brazil, Russia
Match confidence
100%
Source feed
ClinicalTrials.gov
Automated source synopsis

A registered PHASE3 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 Registry status: Withdrawn.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 3
Study design
RANDOMIZED · PARALLEL · TREATMENT · DOUBLE
Evidence population
Human clinical study registration
Participants
0
Population
ALL · 50 Years to 80 Years
Duration
Not reported
Intervention
Bevacizumab; Ranibizumab
Comparator
Lucentis®
Outcomes measured
• Proportion of patients losing fewer than 15 letters on EDTRS chart at month 12 — week 52; • Frequency of ocular and systemic adverse events (AE) and serious adverse events (SAE) that are related, in Investigat…; • Frequency of AE and SAE with toxicity level of 3-4 that are related, in Investigator's opinion, to AMD therapy — week…; • Number of cases of early withdrawal from the study caused by AE or SAE — week 52; • Number of patients who have binding and neutralizing antibodies to BCD-021/Lucentis in serum at screening and month 1…; • The mean titer of binding and neutralizing antibodies to BCD-021/Lucentis in serum at screening and month 12 — screen…; • Mean change in VA score, measured on the EDTRS scale at month 12 — week 52; • Average number of injections and time before re-injection — week 52; • Lesion size at month 6 and month 12 (by angiography) — week 26, 52; • Lesion leakage at month 6 and month 12 — week 26, 52; • Change in fluid and foveal thickness on OCT during the study — week 52; • Retinal sensitivity measured by microperimetry at screening, at month 6 and month 12 — screening, week 26, 52; • Timing of visual improvement after initiation of therapy — week 52
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 3A 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.