Macular Degeneration
Conditions
Keywords
Macular degeneration, Safety, Non-interventional, Non-randomized
Brief summary
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.
Detailed description
No comparator Patients with age-related macular degeneration
Interventions
DRUGMacugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.
Sponsors
Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Neovascular AMD patients who are eligible for Macugen therapy based on the approved label
Exclusion criteria
* Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Baseline up to 2 years | 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. |
| Incidence of POAEs Per Injection Reported by Gender (Females) | Baseline up to 2 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Baseline up to 2 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. |
| Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Baseline up to 2 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. |
| Incidence of POAEs Per Injection Reported by Gender (Males) | Baseline up to 2 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. |
| Number of Participants With Serious Hypersensitivity Reactions | Baseline up to 2 years | 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. |
| Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Baseline up to 2 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. |
| Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) | Baseline up to 2 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. |
Countries
Belgium, Cyprus, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Slovakia, Spain, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 403 |
| 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. | 16 |
| 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. | 75 |
| 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. | 7 |
| Total | 501 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 |
| Overall Study | Death | 7 | 0 | 0 | 0 |
| Overall Study | Insufficient clinical response | 5 | 1 | 5 | 0 |
| Overall Study | Lost to Follow-up | 11 | 0 | 1 | 0 |
| Overall Study | Other | 12 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 31 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Macugen | Macugen and Avastin | Macugen and Lucentis | Macugen and Other AMD Drugs |
|---|---|---|---|---|---|
| Age, Customized 51 to 64 years | 79 participants | 68 participants | 1 participants | 9 participants | 1 participants |
| Age, Customized 65 to 74 years | 149 participants | 121 participants | 7 participants | 19 participants | 2 participants |
| Age, Customized greater than or equal to (≥) 75 years | 268 participants | 209 participants | 8 participants | 47 participants | 4 participants |
| Age, Customized less than or equal to (≤) 50 years | 5 participants | 5 participants | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 307 Participants | 245 Participants | 11 Participants | 46 Participants | 5 Participants |
| Sex: Female, Male Male | 194 Participants | 158 Participants | 5 Participants | 29 Participants | 2 Participants |
| Smoking status Current smoker | 43 participants | 34 participants | 1 participants | 8 participants | 0 participants |
| Smoking status Exsmoker | 130 participants | 103 participants | 3 participants | 22 participants | 2 participants |
| Smoking status Never smoked | 327 participants | 265 participants | 12 participants | 45 participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 65 / 403 | 4 / 16 | 14 / 75 | 4 / 7 |
| serious Total, serious adverse events | 21 / 403 | 0 / 16 | 2 / 75 | 0 / 7 |
Outcome results
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.
Time frame: Baseline up to 2 years
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Increased IOP | 1.34 percent per injection |
| Macugen | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Vitreous hemorrhage | 0.10 percent per injection |
| Macugen | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Traumatic cataract | 0.13 percent per injection |
| Macugen | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Retinal detachment | 0.03 percent per injection |
| Macugen | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Retinal tear | 0.03 percent per injection |
| Macugen | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Endophthalmitis | 0 percent per injection |
| Macugen and Avastin | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Endophthalmitis | 0 percent per injection |
| Macugen and Avastin | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Retinal detachment | 0 percent per injection |
| Macugen and Avastin | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Increased IOP | 2.19 percent per injection |
| Macugen and Avastin | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Traumatic cataract | 0 percent per injection |
| Macugen and Avastin | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Vitreous hemorrhage | 0.73 percent per injection |
| Macugen and Avastin | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Retinal tear | 0 percent per injection |
| Macugen and Lucentis | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Vitreous hemorrhage | 0 percent per injection |
| Macugen and Lucentis | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Traumatic cataract | 0 percent per injection |
| Macugen and Lucentis | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Retinal detachment | 0 percent per injection |
| Macugen and Lucentis | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Endophthalmitis | 0 percent per injection |
| Macugen and Lucentis | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Retinal tear | 0 percent per injection |
| Macugen and Lucentis | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Increased IOP | 0.48 percent per injection |
| Macugen and Other AMD Drugs | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Retinal tear | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Endophthalmitis | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Vitreous hemorrhage | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Retinal detachment | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Increased IOP | 2.50 percent per injection |
| Macugen and Other AMD Drugs | Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection | Traumatic cataract | 0 percent per injection |
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.
Time frame: Baseline up to 2 years
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Incidence of POAEs Per Injection Reported by Gender (Females) | Traumatic cataract | 0.17 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Gender (Females) | Endophthalmitis | 0 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Gender (Females) | Increased IOP | 1.12 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Gender (Females) | Traumatic cataract | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Gender (Females) | Endophthalmitis | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Gender (Females) | Increased IOP | 3.19 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Gender (Females) | Traumatic cataract | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Gender (Females) | Increased IOP | 0.78 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Gender (Females) | Endophthalmitis | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Gender (Females) | Traumatic cataract | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Gender (Females) | Endophthalmitis | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Gender (Females) | Increased IOP | 3.70 percent per injection |
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.
Time frame: Baseline up to 2 years
Population: Safety Population subset of participants ≤50 years old
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) | Endophthalmitis | 0 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) | Vitreous hemorrhage | 0 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) | Traumatic cataract | 0 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) | Increased IOP | 0 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) | Retinal detachment | 0 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years) | Retinal tear | 0 percent per injection |
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.
Time frame: Baseline up to 2 years
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Increased IOP | 2.17 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Endophthalmitis | 0 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Retinal tear | 0.18 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Increased IOP | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Endophthalmitis | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Retinal tear | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Retinal tear | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Increased IOP | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Endophthalmitis | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Increased IOP | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Endophthalmitis | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years) | Retinal tear | 0 percent per injection |
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.
Time frame: Baseline up to 2 years
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Increased IOP | 2.04 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Retinal detachment | 0.11 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Endophthalmitis | 0 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Traumatic cataract | 0.21 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Vitreous hemorrhage | 0.11 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Traumatic cataract | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Retinal detachment | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Increased IOP | 4.62 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Vitreous hemorrhage | 1.54 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Endophthalmitis | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Retinal detachment | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Endophthalmitis | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Vitreous hemorrhage | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Increased IOP | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Traumatic cataract | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Endophthalmitis | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Vitreous hemorrhage | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Traumatic cataract | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Retinal detachment | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years) | Increased IOP | 0 percent per injection |
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.
Time frame: Baseline up to 2 years
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Endophthalmitis | 0 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Increased IOP | 0.62 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Vitreous hemorrhage | 0.14 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Traumatic cataract | 0.14 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Traumatic cataract | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Endophthalmitis | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Increased IOP | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Vitreous hemorrhage | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Traumatic cataract | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Endophthalmitis | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Vitreous hemorrhage | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Increased IOP | 0.79 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Endophthalmitis | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Traumatic cataract | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Increased IOP | 5.26 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years) | Vitreous hemorrhage | 0 percent per injection |
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.
Time frame: Baseline up to 2 years
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Incidence of POAEs Per Injection Reported by Gender (Males) | Retinal detachment | 0.08 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Gender (Males) | Increased IOP | 1.67 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Gender (Males) | Retinal tear | 0.08 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Gender (Males) | Vitreous hemorrhage | 0.25 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Gender (Males) | Traumatic cataract | 0.08 percent per injection |
| Macugen | Incidence of POAEs Per Injection Reported by Gender (Males) | Endophthalmitis | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Gender (Males) | Traumatic cataract | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Gender (Males) | Vitreous hemorrhage | 2.33 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Gender (Males) | Retinal tear | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Gender (Males) | Retinal detachment | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Gender (Males) | Endophthalmitis | 0 percent per injection |
| Macugen and Avastin | Incidence of POAEs Per Injection Reported by Gender (Males) | Increased IOP | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Gender (Males) | Endophthalmitis | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Gender (Males) | Increased IOP | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Gender (Males) | Retinal tear | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Gender (Males) | Traumatic cataract | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Gender (Males) | Retinal detachment | 0 percent per injection |
| Macugen and Lucentis | Incidence of POAEs Per Injection Reported by Gender (Males) | Vitreous hemorrhage | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Gender (Males) | Endophthalmitis | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Gender (Males) | Retinal tear | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Gender (Males) | Increased IOP | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Gender (Males) | Vitreous hemorrhage | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Gender (Males) | Traumatic cataract | 0 percent per injection |
| Macugen and Other AMD Drugs | Incidence of POAEs Per Injection Reported by Gender (Males) | Retinal detachment | 0 percent per injection |
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.
Time frame: Baseline up to 2 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Macugen | Number of Participants With Serious Hypersensitivity Reactions | 0 participants |
| Macugen and Avastin | Number of Participants With Serious Hypersensitivity Reactions | 0 participants |
| Macugen and Lucentis | Number of Participants With Serious Hypersensitivity Reactions | 0 participants |
| Macugen and Other AMD Drugs | Number of Participants With Serious Hypersensitivity Reactions | 0 participants |