Neovascular Age-related Macular DegenerationPhase 1NCT02450981
Evaluation the Pharmacokinetics, Safety, Tolerability of BCD-021 in Patients With Neovascular Age-related Macular Degeneration
A Phase 1 study testing Bevacizumab (BCD-021) in people with Neovascular Age-related Macular Degeneration, run by Biocad.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Bevacizumab (BCD-021)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- in case of occult neovessels, proof required of recent development of the lesion: loss of VA of at least 5 letters ETDRS in the last 3 months OR appearance of a subretinal hemorrhage OR increase in the size of the lesion (> 10%) using fluorescein angiography during the last month by comparison with the last 3 months OR appearance of OCT criteria of macular oedema type, serous separation of neuro-epithelium, separation of the pigmented epithelial during the last month before inclusion to trial;
- 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.
Who cannot join
- 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;
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- 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;
- Former corneal grafting of the studied eye;
- Medical history of auto-immune or idiopathic uveitis;
- Proved diabetic retinopathy;
- Intra-ocular pressure ≥ 25 mmHg despite two topical hypotonic treatments;
- Medical history of intra-ocular surgery within 2 months before the first injection in the studied eye;
- Aphakia or lack of lens capsule (not removed by laser) in the studied eye;
- Any illness or ocular condition that would require an intra-ocular surgery in the studied eye within 12 months after the inclusion;
- Known hypersensitivity to bevacizumab or another drug composite of the medicinal products used; allergy to anaesthetic eye drops;
- Arterial hypertension that is not controlled by an appropriate treatment;
- Previous or current treatment with systemic administration of bevacizumab;
- Pregnancy and breast-feeding;
- Any determined immunodeficiency;
- Syphilis, HIV, hepatitis B, any history of hepatitis C virus;
- Any mental disorder that can create a risk for the patient or influence the patient's ability to follow the study protocol;
- Drug addiction, alcoholism.
- Presence or history of malignant neoplasm (including lymphoproliferative disease);
- Simultaneous participation in any other clinical trial.
About this study
Official title: Multicentre Open Label Non-randomized Clinical Study Evaluating Pharmacokinetics, Safety, Tolerability of Multiple Intravitreal Injections of BCD-021 (CJSC BIOCAD, Russia) in Patients With Neovascular Wet Age-related Macular Degeneration
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.
Read the detailed description
BCD-021-1 is an open label, non-comparative, non-randomized, multicenter phase 1 clinical study evaluating pharmacokinetics, safety and tolerability of multiple intravitreal injections of BCD-021 (bevacizumab biosimilar, CJSC BIOCAD) when given in patients with exudative (wet) age-related macular degeneration.
The study will enrol 10 patients with confirmed neovascular wet age-related macular degeneration. Before inclusion into the active phase of the study, patients will undergo a diagnostic examination during the screening period with a maximum duration of 28 days.
The principal part of the study includes the period from the first intravitreal injection and until 28 days after the third intravitreal injection. The goal of this stage is to evaluate pharmacokinetics, the safety and tolerability of multiple intravitreal injections of BCD-021 (CJSC BIOCAD, Russia) when used in patients with neovascular wet age-related macular degeneration.
Extension phase of the study (month 4 - month 12) is required to assess the long-term effects of the therapy and get full information about the immunogenicity of the study drug.
- Being tested
- Bevacizumab (BCD-021)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab (BCD-021)Drug
Also called Avastin
Bevacizumab is a monoclonal antibody against vascular endothelial growth factor A (VEGF-A)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bevacizumab (BCD-021) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Number of cases of early withdrawal from the study caused by AE or SAE
Measured: 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
Measured: 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
Measured: 28 days
Minimum concentration of bevacizumab between the first and the third administration of BCD-021
Measured: 28 days
Number of patients who have binding and neutralizing antibodies to BCD-021 in serum at screening, after 3 intravitreal injections and after 12 intravitreal injections of BCD-021
Measured: 12 months
Mean change in visual acuity score, measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale at month 12
Measured: 12 months
Change in fluid and foveal thickness on OCT during the study
Measured: 12 months
Timing of visual improvement after initiation of therapy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Ivanov, Phd, Study chair, CJCS BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450981
- Sponsor's protocol ID
- BCD-021-1
- Status last verified
- Mar 2016
- First submitted
- 19 May 2015
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Open Label Non-randomized Clinical Study Evaluating Pharmacokinetics, Safety, Tolerability of Multiple Intravitreal Injections of BCD-021 (CJSC BIOCAD, Russia) in Patients With Neovascular Wet Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02450981
- Acronym / sponsor ID
- BCD-021-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Primary completion
- Mar 2016 (estimated)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BCD-021-1 is an open label, non-comparative, non-randomized, multicenter phase 1 clinical study evaluating pharmacokinetics, safety and tolerability of multiple intravitreal injections of BCD-021 (bevacizumab biosimilar, CJSC BIOCAD) when given in patients with exudative (wet) age-related macular degeneration.
The study will enrol 10 patients with confirmed neovascular wet age-related macular degeneration. Before inclusion into the active phase of the study, patients will undergo a diagnostic examination during the screening period with a maximum duration of 28 days.
The principal part of the study includes the period from the first intravitreal injection and until 28 days after the third intravitreal injection. The goal of this stage is to evaluate pharmacokinetics, the safety and tolerability of multiple intravitreal injections of BCD-021 (CJSC BIOCAD, Russia) when used in patients with neovascular wet age-related macular degeneration.
Extension phase of the study (month 4 - month 12) is required to assess the long-term effects of the therapy and get full information about the immunogenicity of the study drug.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCD-021 group | Experimental | Drug: Bevacizumab (BCD-021)BCD-021 (bevacizumab) at a dose of 1.25 mg, administered as single intravitreal injection every 28 days up to 12 months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (32 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab (BCD-021)Also: AvastinBevacizumab is a monoclonal antibody against vascular endothelial growth factor A (VEGF-A) | Drug | BCD-021 group |
Primary outcome
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
Time frame: 85 days
9 secondary outcomes
Frequency of ocular and systemic AEs and SAEs related to age-related macular degeneration (AMD) therapy, appeared within the whole study period
Time frame: 12 months
Number of cases of early withdrawal from the study caused by AE or SAE
Time frame: 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
Time frame: 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
Time frame: 28 days
Minimum concentration of bevacizumab between the first and the third administration of BCD-021
Time frame: 28 days
Number of patients who have binding and neutralizing antibodies to BCD-021 in serum at screening, after 3 intravitreal injections and after 12 intravitreal injections of BCD-021
Time frame: 12 months
Mean change in visual acuity score, measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale at month 12
Time frame: 12 months
Change in fluid and foveal thickness on OCT during the study
Time frame: 12 months
Timing of visual improvement after initiation of therapy
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman Ivanov, Phd study chair
CJCS BIOCAD
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bevacizumab (BCD-021) in people with Neovascular Age-related Macular Degeneration, run by Biocad.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.