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The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Ranibizumab or combination of Ranibizumab And Dexamethasone under pro re nata treatment regimen for Diabetic Macular Edema patients.
The aim of this study is to evaluate the clinical outcome after intraocular injections of Ranibizumab or combination of Ranibizumab and Dexamethasone under pro re nata treatment regimen for the patients with Diabetic Macular Edema 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic ME: Ranibizumab and intravitreal Dexamethasone | Experimental | Participants with diabetic macular edema will receive a combination of Ranibizumab and intravitreal Dexamethasone |
|
| Diabetic ME: Ranibizumab | Active Comparator | Participants with diabetic macular edema (ME) will receive Ranibizumab only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab Ophthalmic and Intravitreal Dexamethasone | Drug | Pro re nata patients with macula edema due to diabetes will receive Ranibizumab. Group A will continue to receive Ranibizumab depending on their clinical status of macular edema |
| 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 at baseline (pre-treatment) and 1 week, 1month, 2 months, 3 months, and 6 months after treatment. | 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 at baseline (pre-treatment) and 1 week, 1month, 2 months, 3 months, and 6 months after treatment. | 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), from baseline to 6 months. | Baseline, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Change in Humphrey 10-2 visual field in the treatment eye |
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Inclusion Criteria:
Patients with diabetic retinopathy and centre involving DMO, as determined by using spectral domain optical coherence tomography (SD-OCT), in one or both eyes with:
Exclusion Criteria:
Eyes of patients will not be included in the study if:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Li, M.D., Ph.D. | Contact | 0411-86525401 | robin_lijun@sina.com | |
| Emmanuel E Pazo, M.D., Ph.D. | Contact | 18612782131 | ericpazo@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei He, M.D., Ph.D. | He Eye Specialist Hospital, Shenyang. | Study Chair |
| Jun Li, M.D., Ph.D. | He Eye Specialist Hospital, Shenyang. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| He Eye Specialist Hospital | Shenyang | Liaoning | 110001 | China |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Drug: Ozurdex intravitreal steroid Other Name: Dexamethasone Intravitreal Implant Drug: Bevacizumab antiVEGF Other Name: Avastin
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|
| Ranibizumab Ophthalmic only | Drug | Group B will initially receive intravitreal Dexamethasone and Ranibizumab and then depending on their clinical status of macular edema, Ranibizumab will be injected. |
|
|
Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months. |
| Baseline, 1 week, 1 month, 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 at baseline and and 6 months. | Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. |
| Mean change in NEI VFQ25 | Scores from NEI VFQ25 questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. | Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. |
| Mean change in EQ-5D 5L | Scores from EQ-5D 5L questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. | Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. |
| Mean change in VisQoL scores | Scores from VisQoL questionnaire will be assessed and compared at baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. | Baseline, 1 week, 1 month, 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 test at baseline, 1 week, 1month, 2 months, 3 months, and 6 months. | Baseline, 1 week, 1 month, 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 at baseline, 1 week, 1month, 2 months, 3 months, and 6 months. | Baseline, 1 week, 1 month, 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 at baseline, 1 week, 1month, 2 months, 3 months, and 6 months. | Baseline, 1 week, 1 month, 2 months, 3 months, and 6 months. |
| Side effects | Side effects are measured by a review of the participant's medical and ophthalmic history. | 1 week, 1 month, 2 months, 3 months, and 6 months. |
| Use of additional treatments (including laser) | Use of additional treatments (including laser) is assessed by the treating ophthalmologist | 1 week, 1 month, 2 months, 3 months, and 6 months. |
| Emmanuel E Pazo, M.D., Ph.D. |
| He Eye Specialist Hospital, Shenyang. |
| Study Director |
| 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 |