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| Name | Class |
|---|---|
| Baghdad Medical City | OTHER |
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The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include:
Brief summary template The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include:
The secondary objectives include:
Patients inclusion criteria include patients both sexes, age over 40 years with type 2 diabetes mellites diagnosed with diabetic maculopathies; those patients with reduced or reducing vision (6/9-6/90) according to visual acuity and significant foveolar thickening on OCT (more than 250 μm).
Researchers will compare patients with intravitreal anti-VEGF treatment, aflibercept or bevacizumab for three successive monthly injections to see if there are any differences in safety and efficacy between the two arms.
Participants will take aflibercept or bevacizumab intravitreally every month for 3 months
Visit the clinic once every 1 month for checkups and assessment the pre- and post- 3 month anti-VEGF treatment values and findings by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab group | Active Comparator | Patients will receive an intravitreal injection of 1.25 mg (in 0.05 ml solution) of bevacizumab once monthly for three consecutive months. |
|
| Aflibercept group | Experimental | Patients will receive an intravitreal injection of 2.0 mg (in 0.05 ml solution) of aflibercept once monthly for three consecutive months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab Injection [Avastin] | Drug | 1.25 mg intravitreal injection given once monthly for three consecutive months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual accuty assessed by snellen chart | The visual outcomes achieved by testing visual acuity by snellen chart | one day before start of treatment, and after 3 months of starting the treatment |
| Central fovial thinkness by OCT | Macular thickness by optical coherence tomography (OCT) | one day before start of treatment, and after 3 months of starting the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Safety profile and adverse events reported Safety profile and adverse events reported with bevacizumab and aflibercept use and their association with changes in functioning changes. | During the three months after starting the treatment till the end of follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baghdad Medical City Complex | Recruiting | Baghdad | 10001 | Iraq |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D007267 | Injections |
| C533178 | aflibercept |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Aflibercept 2Mg/0.05Ml Inj,Oph | Drug | 2.0 mg intravitreal injection given once monthly for three consecutive months. |
|
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| Quality of life assessed by Visual Functioning Questionnaire 25 (ARB-VFQ-25) | Quality of life-related to visual functioning will be assessed using the Arabic version of the Visual Functioning Questionnaire 25 (ARB-VFQ-25). The ARB-VFQ-25 will be assessed and validated before the start of data collection. | one day before start of treatment, and after 3 months of starting the treatment |
| Adherence assessed by Adherence Barriers Questionnaire of Intravitreal Therapy (ABQ-IVT) | Assessment and validation of the Arabic version of the Adherence Barriers Questionnaire of Intravitreal Therapy (ABQ-IVT) and studying the barriers to adherence that may affect intravitreal drug use. | one day before start of treatment, and after 3 months of starting the treatment |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |