Trial Outcomes & Findings for A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life. (NCT NCT00549055)

Results Overview

Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.

Recruitment status

COMPLETED

Target enrollment

38 participants

Primary outcome timeframe

Baseline, Month 24 or Early Termination

Results posted on

2018-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Macugen Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Overall Study STARTED	38
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Macugen Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Overall Study Adverse Event	4
Overall Study Lack of Efficacy	18
Overall Study Stabilization	5
Overall Study Progression to fibrosis	2
Overall Study Decrease of size	1
Overall Study Active choroidal neovascula increased	1
Overall Study Vitreous hemorrhage	1
Overall Study Growth choroidal neovascularisation	1
Overall Study Choroidal neovascularization	1
Overall Study Very low visual acuity (VA)	1

Baseline Characteristics

A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Macugen n=38 Participants Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Age, Customized < 65 years	3 Participants n=5 Participants
Age, Customized 65 to 74 years	8 Participants n=5 Participants
Age, Customized 75 to 84 years	22 Participants n=5 Participants
Age, Customized >= 85 years	5 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 24 or Early Termination

Population: The Full Analysis Set (FAS) was derived from the set of all enrolled participants who were administered at least 1 injection of the study medication and had at least 1 post Baseline efficacy measurement. Participants analyzed refers to number of participants with analyzable data.

Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.

Outcome measures

Outcome measures
Measure	Macugen n=28 Participants Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Change From Baseline to Final Visit in Visual Acuity (VA) Score	-0.044 Scores on scale Standard Deviation 0.122

SECONDARY outcome

Timeframe: Months 3, 6, 9 and 12

Population: FAS; n= number of participants with analyzable data.

Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits.

Outcome measures

Outcome measures
Measure	Macugen n=30 Participants Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Number of Participants With Change in VA: Improvement Month 3 (n=18)	3 Participants
Number of Participants With Change in VA: Improvement Month 6 (n=5)	1 Participants
Number of Participants With Change in VA: Improvement Month 9 (n=2)	1 Participants
Number of Participants With Change in VA: Improvement Month 12 (n=2)	1 Participants

SECONDARY outcome

Timeframe: Months 3, 6, 9 and 12

Population: FAS; n= number of participants with analyzable data.

Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.

Outcome measures

Outcome measures
Measure	Macugen n=30 Participants Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Number of Participants With Change in VA: Stabilization Month 3 (n=18)	11 Participants
Number of Participants With Change in VA: Stabilization Month 6 (n=5)	2 Participants
Number of Participants With Change in VA: Stabilization Month 9 (n=2)	0 Participants
Number of Participants With Change in VA: Stabilization Month 12 (n=2)	1 Participants

SECONDARY outcome

Timeframe: Months 3, 6, 9 and 12

Population: FAS; n= number of participants with analyzable data.

Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.

Outcome measures

Outcome measures
Measure	Macugen n=30 Participants Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Number of Participants With Change in VA: Worsening Month 3 (n=18)	4 Participants
Number of Participants With Change in VA: Worsening Month 6 (n=5)	2 Participants
Number of Participants With Change in VA: Worsening Month 9 (n=2)	1 Participants
Number of Participants With Change in VA: Worsening Month 12 (n=2)	0 Participants

SECONDARY outcome

Timeframe: Baseline up to 28.4 months

Population: FAS

Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen).

Outcome measures

Outcome measures
Measure	Macugen n=30 Participants Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Duration of Treatment	4.66 Months Standard Deviation 5.26

SECONDARY outcome

Timeframe: Baseline up to 28.4 months

Population: FAS

Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment.

Outcome measures

Outcome measures
Measure	Macugen n=30 Participants Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Frequency of Macugen Administration	7.74 Weeks per injection Standard Deviation 4.80

SECONDARY outcome

Timeframe: Months 3, 6, 9 and 12

Population: FAS

Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).

Outcome measures

Outcome measures
Measure	Macugen n=30 Participants Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments	4 Participants

Adverse Events

Macugen

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Macugen n=38 participants at risk Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
Eye disorders Myodesopsia	5.3% 2/38 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER