Study To Evaluate Safety And Tolerability Of Pegaptanib Sodium In Patients With Diabetic Macular Edema
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: pegaptanib sodium arm 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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).
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kuopion Yliopistollinen sairaala | Kuopio | Finland | 70210 | |
| 2 | PHSOTEY / Silmätautien klinikka | Lahti | Finland | 15850 | |
| 3 | Hospital Naval Del Ferrol | Ferrol | A Coruña | Spain | 15405 |
| 4 | Hospital Ntra. Sra. de La Esperanza | Santiago de Compostela | La Coruña | Spain | 15705 |
| 5 | Hospital Universitari Sant Joan de Reus | Reus | Tarragona | Spain | 43204 |
| 6 | Hospital Universitari de Girona Dr. Josep Trueta | Girona | Spain | 17007 | |
| 7 | Hospital Universitario Clinico San Carlos | Madrid | Spain | 28040 | |
| 8 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 9 | Stockholms Ogonklinik | Stockholm | Sweden | 114 86 | |
| 10 | Ogonkliniken, Centrallasarettet | Vasteras | Sweden | 721 89 | |
| 11 | Frimley Park Hospital | Frimley | Camberley, Surrey | United Kingdom | GU15 3UW |
| 12 | Kings College Hospital | London | United Kingdom | SE5 9RS |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A5751036
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Macugen |
|---|---|
| Arm/Group Description | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. |
| Period Title: Overall Study | |
| STARTED | 46 |
| COMPLETED | 12 |
| NOT COMPLETED | 34 |
Baseline Characteristics
| Arm/Group Title | Macugen |
|---|---|
| Arm/Group Description | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. |
| Overall Participants | 46 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
65.0
(10.6)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
16
34.8%
|
| Male |
30
65.2%
|
Outcome Measures
| Title | Incidence of Ocular and Non-Ocular Adverse Events (AEs) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Macugen |
|---|---|
| Arm/Group Description | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. |
| Measure Participants | 46 |
| Ocular AEs |
10
21.7%
|
| Non-ocular AEs |
8
17.4%
|
| Title | Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all enrolled participants who received at least 1 dose of study medication. |
| Arm/Group Title | Macugen |
|---|---|
| Arm/Group Description | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. |
| Measure Participants | 46 |
| Ocular SAEs |
0
0%
|
| Non-ocular SAEs |
3
6.5%
|
| Title | Mean Total Number of Injections |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all enrolled participants who received at least 1 dose of study medication. |
| Arm/Group Title | Macugen |
|---|---|
| Arm/Group Description | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. |
| Measure Participants | 46 |
| Mean (Standard Deviation) [injections] |
3.24
(1.037)
|
| Title | Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment) |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Macugen |
|---|---|
| Arm/Group Description | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. |
| Measure Participants | 42 |
| Baseline (n= 42) |
58.93
(16.468)
|
| Change at Week 48 (n= 14) |
2.21
(7.536)
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | 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. | |
| Arm/Group Title | Macugen | |
| Arm/Group Description | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. | |
All Cause Mortality |
||
| Macugen | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Macugen | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/46 (6.5%) | |
| Cardiac disorders | ||
| Myocardial infarction | 1/46 (2.2%) | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Lung neoplasm malignant | 1/46 (2.2%) | |
| Nervous system disorders | ||
| Cerebrovascular accident | 1/46 (2.2%) | |
Other (Not Including Serious) Adverse Events |
||
| Macugen | ||
| Affected / at Risk (%) | # Events | |
| Total | 16/46 (34.8%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 1/46 (2.2%) | |
| Eye disorders | ||
| Cataract | 1/46 (2.2%) | |
| Conjunctival haemorrhage | 1/46 (2.2%) | |
| Conjunctival hyperaemia | 1/46 (2.2%) | |
| Conjunctivitis | 1/46 (2.2%) | |
| Eye discharge | 1/46 (2.2%) | |
| Eye pain | 1/46 (2.2%) | |
| Eye pruritus | 1/46 (2.2%) | |
| Eyelid ptosis | 1/46 (2.2%) | |
| Macular oedema | 3/46 (6.5%) | |
| Maculopathy | 1/46 (2.2%) | |
| Uveitis | 1/46 (2.2%) | |
| Visual acuity reduced | 2/46 (4.3%) | |
| Vitreous floaters | 1/46 (2.2%) | |
| Gastrointestinal disorders | ||
| Diarrhoea | 1/46 (2.2%) | |
| Gastric polyps | 1/46 (2.2%) | |
| Gastrointestinal hypermotility | 1/46 (2.2%) | |
| Hiatus hernia | 1/46 (2.2%) | |
| General disorders | ||
| Asthenia | 1/46 (2.2%) | |
| Infections and infestations | ||
| Gastroenteritis | 1/46 (2.2%) | |
| Upper respiratory tract infection | 1/46 (2.2%) | |
| Investigations | ||
| Biopsy vocal cord | 1/46 (2.2%) | |
| Carcinoembryonic antigen increased | 1/46 (2.2%) | |
| Intraocular pressure increased | 1/46 (2.2%) | |
| Nervous system disorders | ||
| Headache | 1/46 (2.2%) | |
| Psychiatric disorders | ||
| Anxiety | 1/46 (2.2%) | |
| Renal and urinary disorders | ||
| Renal colic | 1/46 (2.2%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 1/46 (2.2%) | |
| Wheezing | 1/46 (2.2%) | |
| Skin and subcutaneous tissue disorders | ||
| Skin reaction | 1/46 (2.2%) | |
| Vascular disorders | ||
| Hypertension | 1/46 (2.2%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
- A5751036