Trial Outcomes & Findings for Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema (NCT NCT01189461)
NCT ID: NCT01189461
Last Updated: 2013-09-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
46 participants
Primary outcome timeframe
Baseline up to 30 days after last dose
Results posted on
2013-09-06
Participant Flow
Participant milestones
| Measure |
Macugen
Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
| Measure |
Macugen
Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
13
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Did not meet entrance criteria
|
3
|
|
Overall Study
Other
|
8
|
Baseline Characteristics
Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Macugen
n=46 Participants
Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
|
|---|---|
|
Age Continuous
|
65.0 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dosePopulation: 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.
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.
Outcome measures
| Measure |
Macugen
n=46 Participants
Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
|
|---|---|
|
Incidence of Ocular and Non-Ocular Adverse Events (AEs)
Ocular AEs
|
10 participants
|
|
Incidence of Ocular and Non-Ocular Adverse Events (AEs)
Non-ocular AEs
|
8 participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Macugen
n=46 Participants
Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
|
|---|---|
|
Mean Total Number of Injections
|
3.24 injections
Standard Deviation 1.037
|
SECONDARY outcome
Timeframe: Baseline up to 30 days after last dosePopulation: Safety analysis set included all enrolled participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Macugen
n=46 Participants
Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
|
|---|---|
|
Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)
Ocular SAEs
|
0 participants
|
|
Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)
Non-ocular SAEs
|
3 participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Macugen
n=42 Participants
Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
|
|---|---|
|
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
|
|
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
|
Adverse Events
Macugen
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Macugen
n=46 participants at risk
Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Macugen
n=46 participants at risk
Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Cataract
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival haemorrhage
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival hyperaemia
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctivitis
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye discharge
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pain
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pruritus
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eyelid ptosis
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Macular oedema
|
6.5%
3/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Maculopathy
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Uveitis
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual acuity reduced
|
4.3%
2/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vitreous floaters
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastric polyps
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Biopsy vocal cord
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Carcinoembryonic antigen increased
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Intraocular pressure increased
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal colic
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
2.2%
1/46
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER