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Effect of pegaptanib sodium 0.3 mg intravitreal injections (Macugen) in intraocular pressure: posthoc analysis from
David S Boyer1, Mauro Goldbaum2, Anita M Leys3
1Retina-Vitreous Associates, Beverly Hills, California, USA.
Objective:
To assess the rate of pegaptanib-associated sustained intraocular pressure (IOP) elevation.
Methods:
A posthoc analysis was conducted on all IOP measurements, except the immediate 30-min postinjection, from all subjects randomised to pegaptanib 0.3 mg or sham injections continuously in the first 2 years of the Vascular endothelial growth factor Inhibition Study in Ocular Neovascularisation (V.I.S.I.O.N.) study. Measurements were taken with Goldmann applanation tonometer or Tonopen, except at baseline and in cases of an IOP reading >30 mm Hg when a Goldmann applanation tonometer was mandatory.
Results:
Of 221 subjects, IOP measurements ≥22 mm Hg were seen in 28/114 and 23/107 subjects of the pegaptanib and sham subgroups, respectively (p=0.6338) and measurements ≥24 mm Hg were observed in eight and eight subjects in the pegaptanib and sham groups, respectively. More than two measurements ≥22 mm Hg occurred in six and 10 subjects (p=0.3025), and more than two measurements ≥24 mm Hg were observed in one and four subjects in the pegaptanib and sham groups, respectively. One patient with sustained IOP elevation in the pegaptanib study group, and four in the sham group, had IOP lowering medication added during the course of the study. No subject required glaucoma surgery.
Conclusions:
In V.I.S.I.O.N., after 2 years, there was no evidence of sustained IOP elevation associated with pegaptanib 0.3 mg use.
Trial Registration Number:
NCT00321997.
Insights
This study found no evidence of sustained intraocular pressure (IOP) elevation with pegaptanib use over two years. Pegaptanib injections did not increase the risk of high IOP in patients during the V.I.S.I.O.N. trial.
Area of Science:
- Ophthalmology
- Clinical Trials
- Pharmacology
Background:
- The V.I.S.I.O.N. study investigated the efficacy of pegaptanib for ocular neovascularization.
- Intraocular pressure (IOP) is a critical factor in eye health and disease management.
- Sustained IOP elevation can lead to conditions like glaucoma.
Purpose of the Study:
- To evaluate the incidence of sustained intraocular pressure (IOP) elevation in patients treated with pegaptanib.
- To determine if pegaptanib (0.3 mg) is associated with a long-term increase in IOP compared to sham injections.
Main Methods:
- A post hoc analysis of IOP measurements from the V.I.S.I.O.N. study (NCT00321997).
- Included data from subjects randomized to pegaptanib 0.3 mg or sham injections over the first two years.
- IOP was measured using Goldmann applanation tonometer or Tonopen, excluding immediate post-injection readings.
Main Results:
- No statistically significant difference in IOP measurements ≥22 mmHg or ≥24 mmHg between pegaptanib and sham groups.
- The frequency of sustained IOP elevation (more than two readings ≥22 mmHg or ≥24 mmHg) was similar in both groups.
- One patient in the pegaptanib group and four in the sham group required IOP-lowering medication; no glaucoma surgery was needed.
Conclusions:
- Two-year treatment with pegaptanib 0.3 mg in the V.I.S.I.O.N. study did not result in sustained intraocular pressure elevation.
- Pegaptanib appears to be safe concerning long-term IOP changes in this patient population.
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