Anti- VGF Inhibitor, Diabetic Macular Edema, Diabetic Retinopathy
Conditions
Keywords
pegaptanib sodium, diabetic macular edema
Brief summary
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.
Interventions
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.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * Subjects, who according to the clinical assessment of the investigator, may benefit from anti-VEGF therapy including those subjects who were participating in the A5751013 study and who, in the investigator's opinion, may benefit from continued pegaptanib sodium therapy.
Exclusion criteria
* Eyes with prior scatter (panretinal) photocoagulation within 4 months prior to baseline or anticipated scatter (panretinal) photocoagulation within the next 6 months. * Presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as non-perfusion for \>1 disc area involving the foveal avascular zone (FAZ - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and/or significant opacification (i.e. striae within 1 disc diameter of the foveal center), or presence of chorioretinal atrophy involving the center of the macula. * Vitreomacular traction determined clinically and/or by optical coherence tomography (OCT), which, in the investigator's opinion, contributes to the macular edema (or causes associated foveal detachment), and would preclude improvement with pegaptanib sodium. * Any other cause of macular edema such as vitreous extension, or entrapment to anterior segment wound, or any retinal vein occlusion involving the macula.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ocular and Non-Ocular Adverse Events (AEs) | Baseline up to 30 days after last dose | 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 Total Number of Injections | Baseline up to Week 48 (End of treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose | 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. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment) | Baseline, 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). |
Countries
Finland, Spain, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Macugen Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Did not meet entrance criteria | 3 |
| Overall Study | Lack of Efficacy | 13 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 8 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Macugen |
|---|---|
| Age Continuous | 65.0 years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 46 |
| serious Total, serious adverse events | 3 / 46 |
Outcome results
Primary
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
Population: Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Same participant may be represented in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Incidence of Ocular and Non-Ocular Adverse Events (AEs) | Ocular AEs | 10 participants |
| Macugen | Incidence of Ocular and Non-Ocular Adverse Events (AEs) | Non-ocular AEs | 8 participants |
Primary
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)
Population: Safety analysis set included all enrolled participants who received at least 1 dose of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Macugen | Mean Total Number of Injections | 3.24 injections | Standard Deviation 1.037 |
Secondary
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)
Population: Full analysis set included all enrolled participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies participants who had BVCA score greater than 0 at baseline and 'n' signifies those who were evaluable at each specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Macugen | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment) | Baseline (n= 42) | 58.93 units on a scale | Standard Deviation 16.468 |
| Macugen | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment) | Change at Week 48 (n= 14) | 2.21 units on a scale | Standard Deviation 7.536 |
Secondary
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
Population: Safety analysis set included all enrolled participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs) | Ocular SAEs | 0 participants |
| Macugen | Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs) | Non-ocular SAEs | 3 participants |