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Diabetic macular edema is a frequent complication of long-standing diabetes mellitus in which fluid leaks into the central part of the retina (macula), leading to reduced vision. This randomized controlled trial will be conducted at Combined Military Hospital, Multan, to compare two commonly used intravitreal anti vascular endothelial growth factor medicines, aflibercept and bevacizumab, in adults aged 30 to 60 years with type 1 or type 2 diabetes mellitus for at least 5 years, central macular thickness of at least 300 micrometers on optical coherence tomography, and reduced baseline visual acuity (20/50 or worse). Eligible participants will be allocated in a 1:1 ratio to receive either intravitreal aflibercept 2.0 mg or intravitreal bevacizumab 1.25 mg, administered monthly for two months, with follow-up assessments at 1 and 2 months. The primary hypothesis is that aflibercept produces a greater average improvement in visual acuity than bevacizumab in this patient group. The primary outcome is the mean change in visual acuity measured as Early Treatment Diabetic Retinopathy Study letter score from baseline to 2 months. The secondary outcome is the mean change in central retinal thickness on optical coherence tomography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Aflibercept | Experimental | Participants will receive intravitreal aflibercept administered as 2.0 mg injection, given monthly for two months. |
|
| Group Bevacizumab | Active Comparator | Participants will receive intravitreal bevacizumab administered as 1.25 mg injection, given monthly for two months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (2.0 mg) | Drug | Intravitreal aflibercept 2.0 mg, administered once monthly for two consecutive months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity Letter Score | The primary outcome is the average change in visual acuity expressed as Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, calculated by converting Snellen visual acuity measurements. The change is determined by subtracting baseline letter score from the letter score measured at follow up. This metric reflects functional improvement in vision. | Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Central Retinal Thickness | The secondary outcome is the average change in central retinal thickness measured in micrometers using optical coherence tomography. The change is calculated by comparing baseline thickness with the value measured at follow up. This outcome reflects anatomical response of the macula to treatment. | Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sana Javed | CMH Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMH Institute of Medical Sciences | Multan | Punjab Province | 66000 | Pakistan |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab | Drug | Intravitreal bevacizumab 1.25 mg, administered once monthly for two consecutive months. |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |