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

NCT02450981 | Withdrawn Phase 1

• 1 other identifier: BCD-021-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical study is a phase 1 study which carried out to to evaluate the safety, pharmacokinetics and tolerability of multiple intravitreal injections of BCD-021(bevacizumab biosimilar candidate manufactured by CJSC BIOCAD, Russia) when used in patients with neovascular wet age-related macular degeneration.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Frequency of ocular and systemic AEs (adverse events) and SAEs (serious adverse events) which are related to BCD-021 and appeared after the first, the second and the third intravitreal injection of BCD-021

  85 days

Secondary Outcomes (9)

• Frequency of ocular and systemic AEs and SAEs related to age-related macular degeneration (AMD) therapy, appeared within the whole study period

  12 months

• 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 bevacizumab after the first administration of BCD-021

  28 days

• Area under the plasma concentration-time curve from 56 days to 84 days, maximum concentration and half life of bevacizumab after the third administration of BCD-021

  28 days

• Minimum concentration of bevacizumab between the first and the third administration of BCD-021

  28 days

Study Arms (1)

BCD-021 group

EXPERIMENTAL

BCD-021 (bevacizumab) at a dose of 1.25 mg, administered as single intravitreal injection every 28 days up to 12 months.

Drug: Bevacizumab (BCD-021)

Interventions

Bevacizumab (BCD-021) DRUG

Bevacizumab is a monoclonal antibody against vascular endothelial growth factor A (VEGF-A)

Also known as: Avastin

BCD-021 group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subject has provided informed consent;
• men and women;
• patients must be from 50 years old;
• wet AMD in the study eye, defined as active choroidal neovascular membrane (CNV) (not previously treated with intravitreal injection of an anti-VEGF drug), including retinal angiomatous proliferation (RAP), with oedema involving the fovea as demonstrated with optical coherence tomography (OCT);
• best corrected VA for the studied eye ranging between 20/32 (6.3/10) and 20/320 (0.6/10) with ETDRS scale;
• size of lesion \< 12 disk area;
• only one eye of each study patient may be recruited into the study;
• patient's ability to follow the protocol procedures;
• male and female patients with normal reproductive function and their sexual partners are aware and willing to use voluntarily reliable methods of contraception during the whole period of the study including the screening period.

You may not qualify if:

• Previous or current treatment with intravitreal injection of an anti-VEGF drug (ranibizumab, bevacizumab, aflibercept or pegaptanib, etc.);
• Other healing treatment in the studied eye during the last 3 months before the first injection;
• Former vitrectomy in the study eye;
• Medical history of photocoagulation in the studied eye;
• Involvement in another clinical study (studied eye and/or the other eye);
• Subretinal hemorrhage reaching the fovea centre, with a size \> 50% of the lesion area;
• Fibrosis or retrofoveal retinal atrophy in the studied eye;
• Retinal pigment epithelial tear reaching the macula in the studied eye;
• Choroidal neovascularisation not related to a AMD in the studied eye;
• Medical history of intravitreal medical device in the studied eye;
• Active or suspected ocular or peri-ocular infection;
• Acute conjunctivitis, keratitis, scleritis, or endophthalmitis;
• Serious active intra-ocular inflammation in the studied eye;
• Macula-foramen of the studied eye;
• Myopia larger than -8 diopter;

Sponsors & Collaborators

• Biocad: lead

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Roman Ivanov, Phd

  CJCS BIOCAD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Primary Completion: March 1, 2016
• Last Updated: March 31, 2016

Record last verified: 2016-03