A Phase 3 interventional study of pegaptanib sodium in Anti- VGF Inhibitor, Diabetic Macular Edema and Diabetic Retinopathy, sponsored by Pfizer. Completed at 12 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-06.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This study will asses sthe safety of pegaptanib sodium in patients with diabetic macular edema. The hypothesis is that pegaptanib is safe and efficacious in patients with diabetic macular edema.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 46 is close to the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
all patients will receive pegaptanib sodium
Drug: pegaptanib sodium
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.
Incidence of Ocular and Non-Ocular Adverse Events (AEs)
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.
Time frame: Baseline up to 30 days after last dose
Mean Total Number of Injections
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.
Time frame: Baseline up to Week 48 (End of treatment)
Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Total number of participants who had ocular and non-ocular SAEs was reported.
Time frame: Baseline up to 30 days after last dose
Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)
VA indicated sharpness or clarity of vision. BCVA assessed by early treatment diabetic retinopathy study chart using 4 meter (m), 1m distance, or if participant was able to count fingers, perceive hand motion or light. At 4m (\>= 20 letters), VA score=number of letters correct plus 30 (credited for 30 letters at 1m); otherwise , VA score=number of letters read correctly at 1m plus number read at 4m (if any). If no letters were read correctly at 4m or 1m, VA score= 0, which were excluded from summary statistics calculation. BVCA score ranged: 0 (poor eyesight) to 78 (best eyesight).
Time frame: Baseline, Week 48 (End of treatment)
| Milestone | Macugen |
|---|---|
| Started | 46 |
| Completed | 12 |
| Not completed | 34 |
| Withdrew: Lack of efficacy | 13 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Adverse event | 2 |
| Withdrew: Did not meet entrance criteria | 3 |
| Withdrew: Other | 8 |
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.
| participants | Macugen |
|---|---|
| Ocular AEs | 10 |
| Non-ocular AEs | 8 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Total number of participants who had ocular and non-ocular SAEs was reported.
| participants | Macugen |
|---|---|
| Ocular SAEs | 0 |
| Non-ocular SAEs | 3 |
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.
| injections | Macugen |
|---|---|
| Mean Total Number of Injections | 3.24 ± 1.037 |
VA indicated sharpness or clarity of vision. BCVA assessed by early treatment diabetic retinopathy study chart using 4 meter (m), 1m distance, or if participant was able to count fingers, perceive hand motion or light. At 4m (\>= 20 letters), VA score=number of letters correct plus 30 (credited for 30 letters at 1m); otherwise , VA score=number of letters read correctly at 1m plus number read at 4m (if any). If no letters were read correctly at 4m or 1m, VA score= 0, which were excluded from summary statistics calculation. BVCA score ranged: 0 (poor eyesight) to 78 (best eyesight).
| units on a scale | Macugen |
|---|---|
| Baseline (n= 42) | 58.93 ± 16.468 |
| Change at Week 48 (n= 14) | 2.21 ± 7.536 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Macugen | — | 3/46 (6.5%) | 16/46 (34.8%) |
| Event | Macugen |
|---|---|
| Myocardial infarctionCardiac disorders | 1/46 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/46 |
| Cerebrovascular accidentNervous system disorders | 1/46 |
| Event | Macugen |
|---|---|
| Macular oedemaEye disorders | 3/46 |
| Visual acuity reducedEye disorders | 2/46 |
| AnaemiaBlood and lymphatic system disorders | 1/46 |
| CataractEye disorders | 1/46 |
| Conjunctival haemorrhageEye disorders | 1/46 |
| Conjunctival hyperaemiaEye disorders | 1/46 |
| ConjunctivitisEye disorders | 1/46 |
| Eye dischargeEye disorders | 1/46 |
| Eye painEye disorders | 1/46 |
| Eye pruritusEye disorders | 1/46 |
| Age Continuous(years) | Macugen |
|---|---|
| Mean | 65.0 ± 10.6 |
| Sex: Female, Male(Participants) | Macugen |
|---|---|
| Female | 16 |
| Male | 30 |
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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