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Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT00460408
Recruitment Status : Completed
First Posted : April 16, 2007
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Time Perspective: Prospective
Condition Macular Degeneration
Intervention Drug: Macugen
Enrollment 501

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 403 16 75 7
Completed 336 13 69 7
Not Completed 67 3 6 0
Reason Not Completed
Adverse Event             1             0             0             0
Death             7             0             0             0
Lost to Follow-up             11             0             1             0
Withdrawal by Subject             31             0             0             0
Insufficient clinical response             5             1             5             0
Other             12             2             0             0
Arm/Group Title Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs Total
Hide Arm/Group Description 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 403 16 75 7 501
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 403 participants 16 participants 75 participants 7 participants 501 participants
less than or equal to (≤) 50 years 5 0 0 0 5
51 to 64 years 68 1 9 1 79
65 to 74 years 121 7 19 2 149
greater than or equal to (≥) 75 years 209 8 47 4 268
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 16 participants 75 participants 7 participants 501 participants
Female
245
  60.8%
11
  68.8%
46
  61.3%
5
  71.4%
307
  61.3%
Male
158
  39.2%
5
  31.3%
29
  38.7%
2
  28.6%
194
  38.7%
Smoking status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 403 participants 16 participants 75 participants 7 participants 501 participants
Never smoked 265 12 45 5 327
Current smoker 34 1 8 0 43
Exsmoker 103 3 22 2 130
[1]
Measure Description: Data missing for 1 participant in Macugen monotherapy reporting group.
1.Primary Outcome
Title Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection
Hide Description 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.
Time Frame Baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 403 16 75 7
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
2975 137 623 80
Measure Type: Number
Unit of Measure: percent per injection
Increased IOP 1.34 2.19 0.48 2.50
Vitreous hemorrhage 0.10 0.73 0 0
Traumatic cataract 0.13 0 0 0
Retinal detachment 0.03 0 0 0
Retinal tear 0.03 0 0 0
Endophthalmitis 0 0 0 0
2.Primary Outcome
Title Incidence of POAEs Per Injection Reported by Gender (Females)
Hide Description 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.
Time Frame Baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 245 11 46 5
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
1780 94 385 54
Measure Type: Number
Unit of Measure: percent per injection
Increased IOP 1.12 3.19 0.78 3.70
Traumatic cataract 0.17 0 0 0
Endophthalmitis 0 0 0 0
3.Secondary Outcome
Title Incidence of POAEs Per Injection Reported by Gender (Males)
Hide Description 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.
Time Frame Baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 158 5 29 2
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
1195 43 238 26
Measure Type: Number
Unit of Measure: percent per injection
Increased IOP 1.67 0 0 0
Vitreous hemorrhage 0.25 2.33 0 0
Traumatic cataract 0.08 0 0 0
Retinal detachment 0.08 0 0 0
Retinal tear 0.08 0 0 0
Endophthalmitis 0 0 0 0
4.Secondary Outcome
Title Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)
Hide Description 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.
Time Frame Baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population subset of participants ≤50 years old
Arm/Group Title Macugen
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 403
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
34
Measure Type: Number
Unit of Measure: percent per injection
Endophthalmitis 0
Vitreous hemorrhage 0
Traumatic cataract 0
Increased IOP 0
Retinal detachment 0
Retinal tear 0
5.Secondary Outcome
Title Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)
Hide Description 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.
Time Frame Baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 68 1 9 1
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
554 10 101 15
Measure Type: Number
Unit of Measure: percent per injection
Increased IOP 2.17 0 0 0
Retinal tear 0.18 0 0 0
Endophthalmitis 0 0 0 0
6.Secondary Outcome
Title Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)
Hide Description 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.
Time Frame Baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 121 7 19 2
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
933 65 144 27
Measure Type: Number
Unit of Measure: percent per injection
Increased IOP 2.04 4.62 0 0
Vitreous hemorrhage 0.11 1.54 0 0
Traumatic cataract 0.21 0 0 0
Retinal detachment 0.11 0 0 0
Endophthalmitis 0 0 0 0
7.Secondary Outcome
Title Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)
Hide Description 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.
Time Frame Baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 209 8 47 4
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
1454 62 378 38
Measure Type: Number
Unit of Measure: percent per injection
Increased IOP 0.62 0 0.79 5.26
Vitreous hemorrhage 0.14 0 0 0
Traumatic cataract 0.14 0 0 0
Endophthalmitis 0 0 0 0
8.Secondary Outcome
Title Number of Participants With Serious Hypersensitivity Reactions
Hide Description 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.
Time Frame Baseline up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Hide Arm/Group Description:
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.
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.
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.
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.
Overall Number of Participants Analyzed 403 16 75 7
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/403 (5.21%)   0/16 (0.00%)   2/75 (2.67%)   0/7 (0.00%) 
Cardiac disorders         
Atrial fibrillation * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Cardiac failure * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Tachycardia * 1  2/403 (0.50%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Endocrine disorders         
Goitre * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Eye disorders         
Angle closure glaucoma * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Vitreous fibrin * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
General disorders         
Chest pain * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Infections and infestations         
Pneumonia * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Urosepsis * 1  0/403 (0.00%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Injury, poisoning and procedural complications         
Cataract traumatic * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Upper limb fracture * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Brain neoplasm * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Colon cancer * 1  1/403 (0.25%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Lymphoma * 1  0/403 (0.00%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Malignant neoplasm of renal pelvis * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Pituitary tumour benign * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Rectal cancer * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Renal neoplasm * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Skin cancer * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Nervous system disorders         
Cerebrovascular accident * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Parkinson’s disease * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Subarachnoid haemorrhage * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders         
Haematuria * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Pulmonary embolism * 1  2/403 (0.50%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Vascular disorders         
Deep vein thrombosis * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Macugen Macugen and Avastin Macugen and Lucentis Macugen and Other AMD Drugs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   65/403 (16.13%)   4/16 (25.00%)   14/75 (18.67%)   4/7 (57.14%) 
Cardiac disorders         
Angina pectoris * 1  0/403 (0.00%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Ear and labyrinth disorders         
Vertigo * 1  1/403 (0.25%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Eye disorders         
Blepharitis * 1  1/403 (0.25%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Blindness * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Blindness unilateral * 1  0/403 (0.00%)  0/16 (0.00%)  1/75 (1.33%)  1/7 (14.29%) 
Cataract * 1  3/403 (0.74%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Choroidal neovascularisation * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Conjunctival haemorrhage * 1  5/403 (1.24%)  1/16 (6.25%)  0/75 (0.00%)  1/7 (14.29%) 
Conjunctival hyperaemia * 1  2/403 (0.50%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Conjunctivitis * 1  1/403 (0.25%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Conjunctivitis allergic * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Dry eye * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Eye irritation * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Eye pain * 1  4/403 (0.99%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Foreign body sensation in eyes * 1  0/403 (0.00%)  1/16 (6.25%)  0/75 (0.00%)  0/7 (0.00%) 
Lacrimation increased * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Meibomianitis * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Ocular hyperaemia * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Ocular hypertension * 1  5/403 (1.24%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Photophobia * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Photopsia * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Retinal haemorrhage * 1  3/403 (0.74%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Scotoma * 1  0/403 (0.00%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Vitreous disorder * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Vitreous floaters * 1  1/403 (0.25%)  0/16 (0.00%)  2/75 (2.67%)  0/7 (0.00%) 
Vitreous haemorrhage * 1  0/403 (0.00%)  1/16 (6.25%)  0/75 (0.00%)  1/7 (14.29%) 
Gastrointestinal disorders         
Diarrhoea * 1  1/403 (0.25%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Inguinal hernia * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Oral discomfort * 1  0/403 (0.00%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Vomiting * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
General disorders         
Discomfort * 1  0/403 (0.00%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Injection site inflammation * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Immune system disorders         
Hypersensitivity * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Infections and infestations         
Bronchitis * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Ear infection viral * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Keratitis herpetic * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Nasopharyngitis * 1  2/403 (0.50%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Viral pharyngitis * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Viral rhinitis * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Injury, poisoning and procedural complications         
Joint dislocation * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Post procedural complication * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Procedural hypotension * 1  0/403 (0.00%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Procedural pain * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Investigations         
Intraocular pressure decreased * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Intraocular pressure increased * 1  26/403 (6.45%)  2/16 (12.50%)  2/75 (2.67%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders         
Tendonitis * 1  0/403 (0.00%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Monoclonal gammopathy * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Nervous system disorders         
Convulsions local * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Dizziness * 1  1/403 (0.25%)  0/16 (0.00%)  2/75 (2.67%)  0/7 (0.00%) 
Dysarthria * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Psychiatric disorders         
Depression * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Renal and urinary disorders         
Renal failure chronic * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders         
Hyperhidrosis * 1  0/403 (0.00%)  0/16 (0.00%)  1/75 (1.33%)  0/7 (0.00%) 
Pruritus * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Rash * 1  1/403 (0.25%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
Vascular disorders         
Hypertension * 1  2/403 (0.50%)  0/16 (0.00%)  0/75 (0.00%)  0/7 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00460408     History of Changes
Other Study ID Numbers: A5751019
First Submitted: April 13, 2007
First Posted: April 16, 2007
Results First Submitted: September 24, 2012
Results First Posted: December 11, 2012
Last Update Posted: December 11, 2012