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The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.
No comparator Patients with age-related macular degeneration
Not provided
Not provided
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational study, no comparator | Observational study of patients with AMD treated with Macugen, no comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macugen | Drug | Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years |
| Incidence of POAEs Per Injection Reported by Gender (Females) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of POAEs Per Injection Reported by Gender (Males) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with age-related macular degeneration
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brussels | 1200 | Belgium | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Macugen | The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes. |
| FG001 | Macugen and Avastin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) |
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. |
| Baseline up to 2 years |
| Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years |
| Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years |
| Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Baseline up to 2 years |
| Number of Participants With Serious Hypersensitivity Reactions | Hypersensitivity reactions include Hypersensitivity, Drug hypersensitivity, Anaphylactic shock, Anaphylactic reaction, Anaphylactoid shock, Angioedema Anaphylactoid reaction, Blepharitis allergic, Dermatitis contact, Dermatitis allergic, Toxic skin eruption, Toxic epidermal necrolysis, Drug eruption, Erythema, Erythema multiforme, Tongue oedema, Pharyngeal oedema, Laryngeal oedema, Latex allergy, Paraesthesia oral, Paraesthesia mucosal, Urticaria, Stevens-Johnson syndrome, Rash, Skin reaction, Acute generalised exanthematous pustulosis, Drug rash with eosinphilia and systemic symptoms. | Baseline up to 2 years |
| Charleroi |
| 6000 |
| Belgium |
| Pfizer Investigational Site | Ieper | 8900 | Belgium |
| Pfizer Investigational Site | Lier | 2500 | Belgium |
| Pfizer Investigational Site | Turnhout | 2300 | Belgium |
| Pfizer Investigational Site | Limassol | 1430 | Cyprus |
| Pfizer Investigational Site | Brno | 625 00 | Czechia |
| Pfizer Investigational Site | Hradec Králové | 500 05 | Czechia |
| Pfizer Investigational Site | Pilsen | 304 60 | Czechia |
| Pfizer Investigational Site | Prague | 10034 | Czechia |
| Pfizer Investigational Site | Prague | 128 08 | Czechia |
| Pfizer Investigational Site | Prague | 169 02 | Czechia |
| Pfizer Investigational Site | Sønderborg | 6400 | Denmark |
| Pfizer Investigational Site | Argonay | 74370 | France |
| Pfizer Investigational Site | Dijon | 21055 | France |
| Pfizer Investigational Site | Grenoble | 38100 | France |
| Pfizer Investigational Site | Le Golfe Juan | 06220 | France |
| Pfizer Investigational Site | Marseille | 13285 | France |
| Pfizer Investigational Site | Rennes | 35033 | France |
| Pfizer Investigational Site | Augsburg | 86156 | Germany |
| Pfizer Investigational Site | Frankfurt | 60318 | Germany |
| Pfizer Investigational Site | Karlsruhe | 76137 | Germany |
| Pfizer Investigational Site | Konstanz | 78462 | Germany |
| Pfizer Investigational Site | Ludwigshafen | 67063 | Germany |
| Pfizer Investigational Site | München | 81675 | Germany |
| Pfizer Investigational Site | Münster | 48145 | Germany |
| Pfizer Investigational Site | Weilheim | 82362 | Germany |
| Pfizer Investigational Site | Heraklion | Crete | 71110 | Greece |
| Pfizer Investigational Site | Nikaia | Piraeus | 18454 | Greece |
| Pfizer Investigational Site | Athens | 10672 | Greece |
| Pfizer Investigational Site | Athens | 115 27 | Greece |
| Pfizer Investigational Site | Athens | 11526 | Greece |
| Pfizer Investigational Site | Heraklion | 71001 | Greece |
| Pfizer Investigational Site | Ioannina | 45500 | Greece |
| Pfizer Investigational Site | Kavala | Greece |
| Pfizer Investigational Site | Thessaloniki | 54636 | Greece |
| Pfizer Investigational Site | Thessaloniki | 54642 | Greece |
| Pfizer Investigational Site | Waterford | Ireland |
| Pfizer Investigational Site | Arona, NO | 28041 | Italy |
| Pfizer Investigational Site | Bologna | 40138 | Italy |
| Pfizer Investigational Site | Cagliari | 09100 | Italy |
| Pfizer Investigational Site | Monza, MI | 20052 | Italy |
| Pfizer Investigational Site | Naples | 80131 | Italy |
| Pfizer Investigational Site | Pisa | 56124 | Italy |
| Pfizer Investigational Site | Rieti | 02100 | Italy |
| Pfizer Investigational Site | Siena | 53100 | Italy |
| Pfizer Investigational Site | Bydgoszcz | 85 - 094 | Poland |
| Pfizer Investigational Site | Szczecin | 70 - 111 | Poland |
| Pfizer Investigational Site | Warsaw | 04-141 | Poland |
| Pfizer Investigational Site | Banská Bystrica | 975 17 | Slovakia |
| Pfizer Investigational Site | Bratislava | 826 06 | Slovakia |
| Pfizer Investigational Site | Bratislava | 851 03 | Slovakia |
| Pfizer Investigational Site | Košice | 041 66 | Slovakia |
| Pfizer Investigational Site | Prešov | 08001 | Slovakia |
| Pfizer Investigational Site | Prešov | 081 81 | Slovakia |
| Pfizer Investigational Site | Ružomberok | 03426 | Slovakia |
| Pfizer Investigational Site | Trenčín | 911 71 | Slovakia |
| Pfizer Investigational Site | Žilina | 012 07 | Slovakia |
| Pfizer Investigational Site | Santiago de Compostela | A Coruña | 15706 | Spain |
| Pfizer Investigational Site | Alcalá de Henares | Madrid | 28805 | Spain |
| Pfizer Investigational Site | Madrid | Madrid | 28040 | Spain |
| Pfizer Investigational Site | Pamplona | Navarre | 31008 | Spain |
| Pfizer Investigational Site | Santa Cruz de Tenerife | Santa Cruz de Tenerife | 38010 | Spain |
| Pfizer Investigational Site | Valencia | Valencia | 46014 | Spain |
| Pfizer Investigational Site | Valencia | Valencia | 46015 | Spain |
| Pfizer Investigational Site | Valladolid | Valladolid | 47010 | Spain |
| Pfizer Investigational Site | Stockholm | 118 83 | Sweden |
| Pfizer Investigational Site | Västerås | 721 89 | Sweden |
The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes. |
| FG002 | Macugen and Lucentis | The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes. |
| FG003 | Macugen and Other AMD Drugs | The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Macugen | The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes. |
| BG001 | Macugen and Avastin | The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes. |
| BG002 | Macugen and Lucentis | The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes. |
| BG003 | Macugen and Other AMD Drugs | The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Smoking status | Data missing for 1 participant in Macugen monotherapy reporting group. | Number | participants |
|
| 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 Pertinent Ocular Adverse Events (POAEs) Per Injection | POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received. | Safety Population: participants who received at least 1 Macugen (pegaptanib sodium) injection; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group. | Posted | Number | percent per injection | Baseline up to 2 years | Injections | Participants |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Incidence of POAEs Per Injection Reported by Gender (Males) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Safety Population subset of male participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group. | Posted | Number | percent per injection | Baseline up to 2 years | Injections | Participants |
| |||||||||||||||||||||||||||||||||||
| Primary | Incidence of POAEs Per Injection Reported by Gender (Females) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Safety Population subset of female participants; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group. | Posted | Number | percent per injection | Baseline up to 2 years | Injections | Participants |
| |||||||||||||||||||||||||||||||||||
| Secondary | Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Safety Population subset of participants ≤50 years old | Posted | Number | percent per injection | Baseline up to 2 years | Injections | Participants |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Safety Population subset of participants 51 to 64 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group. | Posted | Number | percent per injection | Baseline up to 2 years | Injections | Participants |
| |||||||||||||||||||||||||||||||||||
| Secondary | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Safety Population subset of participants 65 to 74 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group. | Posted | Number | percent per injection | Baseline up to 2 years | Injections | Participants |
| |||||||||||||||||||||||||||||||||||
| Secondary | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received. | Safety Population subset of participants ≥ 75 years of age; in addition to endophthalmitis, results for POAE categories presented if number of specific POAEs was ≥1 in at least 1 reporting group. | Posted | Number | percent per injection | Baseline up to 2 years | Injections | Participants |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Hypersensitivity Reactions | Hypersensitivity reactions include Hypersensitivity, Drug hypersensitivity, Anaphylactic shock, Anaphylactic reaction, Anaphylactoid shock, Angioedema Anaphylactoid reaction, Blepharitis allergic, Dermatitis contact, Dermatitis allergic, Toxic skin eruption, Toxic epidermal necrolysis, Drug eruption, Erythema, Erythema multiforme, Tongue oedema, Pharyngeal oedema, Laryngeal oedema, Latex allergy, Paraesthesia oral, Paraesthesia mucosal, Urticaria, Stevens-Johnson syndrome, Rash, Skin reaction, Acute generalised exanthematous pustulosis, Drug rash with eosinphilia and systemic symptoms. | Safety Population | Posted | Number | participants | Baseline up to 2 years |
|
Not provided
The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Macugen | The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes. | 21 | 403 | 65 | 403 | ||
| EG001 | Macugen and Avastin | The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes. | 0 | 16 | 4 | 16 | ||
| EG002 | Macugen and Lucentis | The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes. | 2 | 75 | 14 | 75 | ||
| EG003 | Macugen and Other AMD Drugs | The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes. | 0 | 7 | 4 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vitreous fibrin | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cataract traumatic | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Malignant neoplasm of renal pelvis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Choroidal neovascularisation | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Foreign body sensation in eyes | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Meibomianitis | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Scotoma | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vitreous disorder | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ear infection viral | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Keratitis herpetic | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Viral rhinitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Intraocular pressure decreased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Monoclonal gammopathy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Convulsions local | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
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 |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C495058 | pegaptanib |
Not provided
Not provided
Not provided
| 51 to 64 years |
|
| 65 to 74 years |
|
| greater than or equal to (≥) 75 years |
|
| Male |
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| Current smoker |
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| Exsmoker |
|
| Injections |
|
| Vitreous hemorrhage |
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| Traumatic cataract |
|
| Retinal detachment |
|
| Retinal tear |
|
| Endophthalmitis |
|
| OG003 | Macugen and Other AMD Drugs | The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes. |
|
|
| OG003 | Macugen and Other AMD Drugs | The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes. |
|
|
| Injections |
|
|
The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
| OG003 | Macugen and Other AMD Drugs | The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes. |
|
|
The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
| OG003 | Macugen and Other AMD Drugs | The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes. |
|
|
The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
| OG003 | Macugen and Other AMD Drugs | The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes. |
|
|
| Macugen and Lucentis |
The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes. |
| OG003 | Macugen and Other AMD Drugs | The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes. |
|
|