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The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery.
As a secondary objective, this study also aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection in patients undergoing pterygium excision and to determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients will receive one injection of ranibizumab 3 days prior to surgery |
|
| 2 | Experimental | Patients will undergo one injection of ranibizumab at the time of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 0.5 mg subconjunctival ranibizumab 3 days prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| This study aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection and determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence. | 2 years |
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Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age > 18 years
Patient related considerations: All patients of both genders will be considered for enrollment.
Disease related considerations:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
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| Name | Affiliation | Role |
|---|---|---|
| Sonia Yoo, MD | Bascom Palmer Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20417925 | Derived | Galor A, Yoo SH, Piccoli FV, Schmitt AJ, Chang V, Perez VL. Phase I study of subconjunctival ranibizumab in patients with primary pterygium undergoing pterygium surgery. Am J Ophthalmol. 2010 Jun;149(6):926-931.e2. doi: 10.1016/j.ajo.2010.01.015. Epub 2010 Apr 24. |
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| ID | Term |
|---|---|
| D011625 | Pterygium |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| ranibizumab | Drug | 0.5 mg subconjunctival ranibizumab at the time of surgery |
|
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |