Abstract
Purpose: To evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients with primary pterygium undergoing pterygium surgery with autograft placement. Design: Prospective, open-label pilot study. Methods: Setting: Single-center, academic practice. Study Population: Ten patients with primary pterygia. bservational Procedure: Subconjunctival ranibizumab (0.5 mg/0.05 mL) administered at the limbus, adjacent to pterygium either 3 days prior to surgery (Group 1, n = 5) or at the time of surgery (Group 2, n = 5). Patients prospectively followed for 6 months after injection. Main Outcome Measures: Safety and tolerability of subconjunctival ranibizumab as determined by patient reporting, clinical examination, and masked observer interpretation of slit-lamp photographs. Results: The median age at presentation was 59 years (range 33 to 71 years); 60% of patients were male. Five patients were randomly assigned to be injected with 0.05 mg ranibizumab via subconjunctival injection 3 days prior to surgery; an additional 5 patients were injected with ranibizumab at the time of surgery. All 10 patients tolerated the injection well. The conjunctival autograft remained intact in the 9 patients whose grafts were secured with sutures. There was dehiscence of the autograft in the 1 patient whose graft was secured with fibrin glue. No other safety concerns arose after 6 months of follow-up. Three pterygium recurrences were noted at 6 months (all patients in Group 1). All remaining patients had a normal surgical bed appearance. Conclusions: The data from this small pilot study suggest that 1 subconjunctival injection of ranibizumab in conjunction with pterygium surgery is well tolerated.
| Original language | English |
|---|---|
| Journal | American Journal of Ophthalmology |
| Volume | 149 |
| Issue number | 6 |
| DOIs | |
| State | Published - Jun 1 2010 |
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ASJC Scopus subject areas
- Ophthalmology
Cite this
Phase I Study of Subconjunctival Ranibizumab in Patients With Primary Pterygium Undergoing Pterygium Surgery. / Galor, Anat; Yoo, Sonia H; Piccoli, Fernanda V R; Schmitt, Artur J.; Chang, Victoria; Perez Quinones, Victor L.
In: American Journal of Ophthalmology, Vol. 149, No. 6, 01.06.2010.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Phase I Study of Subconjunctival Ranibizumab in Patients With Primary Pterygium Undergoing Pterygium Surgery
AU - Galor, Anat
AU - Yoo, Sonia H
AU - Piccoli, Fernanda V R
AU - Schmitt, Artur J.
AU - Chang, Victoria
AU - Perez Quinones, Victor L
PY - 2010/6/1
Y1 - 2010/6/1
N2 - Purpose: To evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients with primary pterygium undergoing pterygium surgery with autograft placement. Design: Prospective, open-label pilot study. Methods: Setting: Single-center, academic practice. Study Population: Ten patients with primary pterygia. bservational Procedure: Subconjunctival ranibizumab (0.5 mg/0.05 mL) administered at the limbus, adjacent to pterygium either 3 days prior to surgery (Group 1, n = 5) or at the time of surgery (Group 2, n = 5). Patients prospectively followed for 6 months after injection. Main Outcome Measures: Safety and tolerability of subconjunctival ranibizumab as determined by patient reporting, clinical examination, and masked observer interpretation of slit-lamp photographs. Results: The median age at presentation was 59 years (range 33 to 71 years); 60% of patients were male. Five patients were randomly assigned to be injected with 0.05 mg ranibizumab via subconjunctival injection 3 days prior to surgery; an additional 5 patients were injected with ranibizumab at the time of surgery. All 10 patients tolerated the injection well. The conjunctival autograft remained intact in the 9 patients whose grafts were secured with sutures. There was dehiscence of the autograft in the 1 patient whose graft was secured with fibrin glue. No other safety concerns arose after 6 months of follow-up. Three pterygium recurrences were noted at 6 months (all patients in Group 1). All remaining patients had a normal surgical bed appearance. Conclusions: The data from this small pilot study suggest that 1 subconjunctival injection of ranibizumab in conjunction with pterygium surgery is well tolerated.
AB - Purpose: To evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients with primary pterygium undergoing pterygium surgery with autograft placement. Design: Prospective, open-label pilot study. Methods: Setting: Single-center, academic practice. Study Population: Ten patients with primary pterygia. bservational Procedure: Subconjunctival ranibizumab (0.5 mg/0.05 mL) administered at the limbus, adjacent to pterygium either 3 days prior to surgery (Group 1, n = 5) or at the time of surgery (Group 2, n = 5). Patients prospectively followed for 6 months after injection. Main Outcome Measures: Safety and tolerability of subconjunctival ranibizumab as determined by patient reporting, clinical examination, and masked observer interpretation of slit-lamp photographs. Results: The median age at presentation was 59 years (range 33 to 71 years); 60% of patients were male. Five patients were randomly assigned to be injected with 0.05 mg ranibizumab via subconjunctival injection 3 days prior to surgery; an additional 5 patients were injected with ranibizumab at the time of surgery. All 10 patients tolerated the injection well. The conjunctival autograft remained intact in the 9 patients whose grafts were secured with sutures. There was dehiscence of the autograft in the 1 patient whose graft was secured with fibrin glue. No other safety concerns arose after 6 months of follow-up. Three pterygium recurrences were noted at 6 months (all patients in Group 1). All remaining patients had a normal surgical bed appearance. Conclusions: The data from this small pilot study suggest that 1 subconjunctival injection of ranibizumab in conjunction with pterygium surgery is well tolerated.
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UR - http://www.scopus.com/inward/citedby.url?scp=77952543569&partnerID=8YFLogxK
U2 - 10.1016/j.ajo.2010.01.015
DO - 10.1016/j.ajo.2010.01.015
M3 - Article
C2 - 20417925
AN - SCOPUS:77952543569
VL - 149
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
SN - 0002-9394
IS - 6
ER -