Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pegaptanib · 4 trials · 7 indications
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Total number of participants who had ocular and non-ocular AEs was reported.
Mean number of injections per participant was calculated as (number of injection administered per participant - 1)/duration of treatment. Mean number of injections administered for total participants was summarized.
Best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events
| Arm | Type | Description |
|---|---|---|
| pegaptanib sodium arm | EXPERIMENTAL | all patients will receive pegaptanib sodium |
| pegaptanib sodium | EXPERIMENTAL | - |
| sham injection | SHAM_COMPARATOR | - |
| EYE001 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| pegaptanib sodium | DRUG | Upon enrollment, all subjects will be treated in the study eye with pegaptanib sodium 0.3 mg at the investigators' discretion based on visual acuity assessment up to a maximum of 48 weeks. The minimum dosing interval between injections will be at least 6 weeks. |
| sham injection | OTHER | sham injection every 6 weeks |
Inclusion Criteria: * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Subjects with documented clinical diagnosis of diabetic macular edema (DME) with proliferative or non proliferative diabetic retinopathy. * Subjec...
Pegaptanib is used for the treatment of macular degeneration and macular edema, including diabetic macular edema. It is an anti-VEGF inhibitor that has been studied in clinical trials for these retinal conditions.
Pegaptanib targets vascular endothelial growth factor (VEGF), functioning as an anti-VEGF inhibitor. By inhibiting VEGF, it aims to reduce abnormal blood vessel growth and leakage in the eye, which are hallmarks of conditions like wet age-related macular degeneration and diabetic macular edema.
Pegaptanib is developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE.
Pegaptanib has completed Phase 3 clinical trials for macular degeneration and diabetic macular edema. It is an investigational drug that has been studied in multiple completed trials, including Phase 2 and Phase 3 studies, but it is not approved for use.
Pegaptanib has been studied in several completed clinical trials, including NCT00150202 and NCT00239928 for wet-type age-related macular degeneration, and NCT01100307 and NCT01189461 for diabetic macular edema. These trials were conducted in countries such as Japan, Finland, Spain, Sweden, and the United Kingdom.
Pegaptanib is also known as EYE001, as seen in clinical trial titles such as 'Clinical Study Of EYE001 For Wet-Type AMD' and 'Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration.'