Phase I study of subconjunctival ranibizumab in patients with primary pterygium undergoing pterygium surgery.
OBJECTIVE
To evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients with primary pterygium undergoing pterygium surgery with autograft placement.


METHODS
Prospective, open-label pilot study.


METHODS



METHODS
Single-center, academic practice.


METHODS
Ten patients with primary pterygia.


METHODS
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.


METHODS
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.
Galor
Anat
A
Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine, Miami, Florida 33136, USA.
Yoo
Sonia H
SH
Piccoli
Fernanda V R
FV
Schmitt
Artur J
AJ
Chang
Victoria
V
Perez
Victor L
VL
D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D003131:Combined Modality Therapy; D003228:Conjunctiva / Q000187:drug effects* / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D013508:Ophthalmologic Surgical Procedures; D010865:Pilot Projects; D011446:Prospective Studies; D011625:Pterygium / Q000188:drug therapy* / Q000601:surgery*; D000069579:Ranibizumab; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors
D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab