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
The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Bevacizumab or combination of Bevacizumab And Dexamethasone under pro re nata treatment regimen for Branch Retinal Vein Occlusion (BRVO) patients.
The aim of this study is to evaluate the clinical outcome after intraocular injections of Bevacizumab or combination of Bevacizumab and Dexamethasone under pro re nata treatment regimen for the patients with Branch Retinal Vein Occlusion (BRVO) patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRVO: Bevacizumab and intravitreal Dexamethasone | Experimental | Participants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone. |
|
| BRVO: Bevacizumab | Active Comparator | Participants with BRVO will receive Bevacizumab only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab Ophthalmic and Intravitreal Dexamethasone | Drug | Pro re nata patients with BRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of BRVO, Bevacizumab will be injected. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in monocular BCVA in the treatment eye | Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared. | Baseline, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Mean change in binocular BCVA | Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared. | Baseline, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in central subfield retinal thickness | Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT) is assessed and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Change in Humphrey 10-2 visual field in the treatment eye |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Li, M.D., Ph.D. | Contact | 0086-15104083505 | robin_lijun@sina.com | |
| Emmanuel E Pazo | Contact | 0086-18612782131 | ericpazo@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei He | He Eye Specialist Hospital, Shenyang. | Study Chair |
| Jun Li | He Eye Specialist Hospital, Shenyang. | Principal Investigator |
| Emmanuel E Pazo |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| He Eye Specialist Hospital | Shenyang | Liaoning | 110001 | China |
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 |
|---|---|
| D000068258 | Bevacizumab |
| D002123 | Calcium Dobesilate |
| 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
|
| Bevacizumab Ophthalmic | Drug | Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected. |
|
|
Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test and compared. |
| Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Number of Bevacizumab. Treatments | Number of injections provided to the patients during the 6 month period. | Day 1 through Month 6 |
| Mean change in NEI VFQ25 | Scores from NEI VFQ25 questionnaire is assessed and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Mean change in EQ-5D 5L | Scores from EQ-5D 5L questionnaire is assessed and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Mean change in VisQoL scores | Scores from VisQoL questionnaire is assessed and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Mean change in wavefront aberrations | Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Mean change in ocular surface and tear-film | Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Mean change in vessel density | Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Side effects | Side effects are measured by a review of the participant's medical and ophthalmic history. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |
| People meeting driving standards | Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |
| He Eye Specialist Hospital, Shenyang. |
| Study Director |
| 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 |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |