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The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding :
Serum Systemic VEGF levels. Retinal Vascularization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A recieved 0.3125mg intravitreal bevacizumab in both eyes | Experimental | 9 infants in group A with type 1 ROP , received 0.3125mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection . |
|
| Group B received 0.625mg intravitreal bevacizumab in both eyes | Active Comparator | 10 infants in group B with type 1 ROP , received 0.625mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Bevacizumab | Drug | Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups. | serum systemic VEGF measured using human VEGF ELISA kit | at day 0 (baseline ) , 1 week and 4 weeks post-injection |
| The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment. | Rescue therapy is defined as the need of a second dose of 0.625 mg bevacizumab reinjection or laser at any time during follow up period. | "up to 60 weeks postmenstrual age" |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any adverse events from intravitreal-injection | endophthalmitis , retinal detachment , cataract , vitreous hemorrhage | Within 4 weeks from intravitreal injection |
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Inclusion Criteria:
Infants with Type 1 ROP according to ETROP study which is defined as:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nooran Abdelkader, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Cairo University | Cairo | 11865 | Egypt |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |