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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pegaptanib sodium arm | Experimental | all patients will receive pegaptanib sodium |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline up to Week 48 (End of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopion Yliopistollinen sairaala | Kuopio | 70210 | Finland | |||
| PHSOTEY / Silmätautien klinikka |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25187694 | Derived | Sivaprasad S, Browning RC, Starita C. An open-label, one-year, noncomparative study to evaluate the safety and tolerability of intravitreal pegaptanib sodium in patients with diabetic macular edema. Clin Ophthalmol. 2014 Aug 21;8:1565-71. doi: 10.2147/OPTH.S68498. eCollection 2014. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Macugen | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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). | Baseline, Week 48 (End of treatment) |
| Lahti |
| 15850 |
| Finland |
| Hospital Naval Del Ferrol | Ferrol | A Coruña | 15405 | Spain |
| Hospital Universitari de Girona Dr. Josep Trueta | Girona | Girona | 17007 | Spain |
| Hospital Ntra. Sra. de La Esperanza | Santiago de Compostela | La Coruña | 15705 | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitari Sant Joan de Reus | Reus | Tarragona | 43204 | Spain |
| Stockholms Ogonklinik | Stockholm | 114 86 | Sweden |
| Ogonkliniken, Centrallasarettet | Västerås | 721 89 | Sweden |
| Frimley Park Hospital | Frimley | Camberley, Surrey | GU15 3UW | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Macugen | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | Baseline up to 30 days after last dose |
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| 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. | Safety analysis set included all enrolled participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 30 days after last dose |
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| 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. | Safety analysis set included all enrolled participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | injections | Baseline up to Week 48 (End of treatment) |
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| 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 48 (End of treatment) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Macugen | Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48. | 3 | 46 | 16 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Eye pruritus | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Eyelid ptosis | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Macular oedema | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Maculopathy | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Uveitis | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Gastric polyps | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Gastrointestinal hypermotility | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
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| Biopsy vocal cord | Investigations | MedDRA v15.0 | Non-systematic Assessment |
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| Carcinoembryonic antigen increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA v15.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Renal colic | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v15.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C495058 | pegaptanib |
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