Trial · NCT00460408

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

NCT00460408, Completed, Pfizer; results first posted 2012-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration. Trials, record NCT00460408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00460408

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration
NCT number: NCT00460408
Status: Completed
Enrollment: 501 participants, actual
Lead sponsor: Pfizer
Conditions: Macular Degeneration
Interventions: Macugen
First posted: 2007-04-16
Last updated: 2012-12-11
Results first posted: 2012-12-11

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Baseline up to 2 years	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.	percent per injection	NUMBER
SECONDARY	Incidence of POAEs Per Injection Reported by Gender (Males)	Baseline up to 2 years	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.	percent per injection	NUMBER
PRIMARY	Incidence of POAEs Per Injection Reported by Gender (Females)	Baseline up to 2 years	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.	percent per injection	NUMBER
SECONDARY	Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)	Baseline up to 2 years	Safety Population subset of participants ≤50 years old	percent per injection	NUMBER
SECONDARY	Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)	Baseline up to 2 years	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.	percent per injection	NUMBER
SECONDARY	Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)	Baseline up to 2 years	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.	percent per injection	NUMBER
SECONDARY	Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)	Baseline up to 2 years	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.	percent per injection	NUMBER
SECONDARY	Number of Participants With Serious Hypersensitivity Reactions	Baseline up to 2 years	Safety Population	participants	NUMBER

Source ClinicalTrials.gov

Results by group118

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Macugen	Increased IOP	1.34	percent per injection
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Macugen and Avastin	Increased IOP	2.19	percent per injection
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Macugen and Lucentis	Increased IOP	0.48	percent per injection
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Macugen and Other AMD Drugs	Increased IOP	2.50	percent per injection
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Macugen	Vitreous hemorrhage	0.10	percent per injection
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Macugen and Avastin	Vitreous hemorrhage	0.73	percent per injection
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Macugen and Lucentis	Vitreous hemorrhage	0	percent per injection
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Macugen and Other AMD Drugs	Vitreous hemorrhage	0	percent per injection
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Macugen	Traumatic cataract	0.13	percent per injection
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	Macugen and Avastin	Traumatic cataract	0	percent per injection

1 to 10 of 118Source ClinicalTrials.gov

See all 118 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Macugen	403
Overall Study	STARTED	Macugen and Avastin	16
Overall Study	STARTED	Macugen and Lucentis	75
Overall Study	STARTED	Macugen and Other AMD Drugs	7
Overall Study	COMPLETED	Macugen	336
Overall Study	COMPLETED	Macugen and Avastin	13
Overall Study	COMPLETED	Macugen and Lucentis	69
Overall Study	COMPLETED	Macugen and Other AMD Drugs	7
Overall Study	NOT COMPLETED	Macugen	67
Overall Study	NOT COMPLETED	Macugen and Avastin	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events328

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Angina pectoris	Cardiac disorders	Macugen	0	403
other	Angina pectoris	Cardiac disorders	Macugen and Avastin	0	16
other	Angina pectoris	Cardiac disorders	Macugen and Lucentis	1	75
other	Angina pectoris	Cardiac disorders	Macugen and Other AMD Drugs	0	7
other	Vertigo	Ear and labyrinth disorders	Macugen	1	403
other	Vertigo	Ear and labyrinth disorders	Macugen and Avastin	0	16
other	Vertigo	Ear and labyrinth disorders	Macugen and Lucentis	1	75
other	Vertigo	Ear and labyrinth disorders	Macugen and Other AMD Drugs	0	7
other	Blepharitis	Eye disorders	Macugen	1	403
other	Blepharitis	Eye disorders	Macugen and Avastin	0	16

1 to 10 of 328Source ClinicalTrials.gov

See all 328 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Macugen
Total, all-cause mortality	Macugen and Avastin
Total, all-cause mortality	Macugen and Lucentis
Total, all-cause mortality	Macugen and Other AMD Drugs
Total, other adverse events	Macugen	65	403
Total, other adverse events	Macugen and Avastin	4	16
Total, other adverse events	Macugen and Lucentis	14	75
Total, other adverse events	Macugen and Other AMD Drugs	4	7
Total, serious adverse events	Macugen	21	403
Total, serious adverse events	Macugen and Avastin	0	16

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00460408

GET https://conductscience.org/api/trials/v1/NCT00460408/results?page=2

API reference For AI assistants