Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to macular edema secondary to BRVO
Following a 14-day maximum screening period, patients will be randomized and followed for approximately 52 weeks. Treatment visits will be scheduled in 4-week intervals. After 6 initial monthly injections of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 24 to week 48). During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an injection or not. Safety and efficacy outcomes will continue to be evaluated up to a period of 52 weeks unless the patient is withdrawn or discontinues the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 601 1.25mg | Experimental |
| |
| Ranibizuman 0.5 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 601 1.25mg | Drug | Solution for injection (intravitreal use) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in best-corrected visual acuity (BCVA) at Week 24 | Assessed with ETDRS visual acuity testing charts. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in BCVA by visit up to Week 12 and Week 52 | Assessed with ETDRS visual acuity testing charts. | Baseline, Week 12 and Week 52 |
| Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA by at Week 12, Week 24 and Week 52 compared to baseline |
Not provided
Inclusion Criteria:
Sign informed consent form and willing to be visited at the time specified in the trial
Male or Female, at least 18 years of age
The study eye must meet the following criteria
BCVA score ≥ 34 letters in the fellow eye, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/200)
Exclusion Criteria:
For Study Eye:
For Any Eye:
General Exclusion Criteria:
Laboratory Exclusion Criteria:
Other Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hong Dai, Bachelor | Beijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BeiJing Hospital | Beijing | Beijing Municipality | 100730 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ranibizuman 0.5 mg | Drug | Solution for injection (intravitreal use) |
|
|
Assessed with ETDRS visual acuity testing charts. |
| Baseline, Week 12, Week 24 and Week 52 |
| Average Change of BCVA From Baseline to Week 4 Through Week 52 | Assessed with ETDRS visual acuity testing charts. | Baseline to Week 52 |
| Average Change of BCVA From Baseline to Week 28 Through Week 52 | Assessed with ETDRS visual acuity testing charts. | Week 28 to Week 52 |
| Change from baseline in central retina thickness (CRT) at Week 12, Week 24 and Week 52 | OCT (optical coherence tomography) was used to assess central retina thickness (CRT) representing the average retinal thickness of the central 1 mm diameter subfield around the foveal center. | baseline, Week 12, Week 24 and Week 52 |
| Number of injections from baseline to Week 52 | Number of administered injections | baseline to Week 52 |
| Number of injections between Week 24 to Week 52 | Number of administered injections | Week 24 to Week 52 |
| Incidence of ocular and non-ocular AEs up to Week 52 | Incidence of ocular and non-ocular AEs | Baseline to Week 52 |
| Blood concentrations of 601 at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24,Week 36 and Week 52 | Steady-state blood concentrations of 601 | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24,Week 36 and Week 52 |
| Blood concentrations of VEGF at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24,Week 36 and Week 52 | Detection of VEGF blood concentration. | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24,Week 36 and Week 52 |
| Immunogenicity of 601 at Baseline, Week 4, Week 12, Week 24, Week 36 and Week 52 | Detection of blood Anti-drug antibody (ADA) status. If ADA was positive, Neutralization antibody (Nab) will be tested. | Baseline, Week 4, Week 12, Week 24, Week 36 and Week 52 |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |