Trial Outcomes & Findings for Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration (NCT NCT00539734)

Results Overview

Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

baseline, 3 months

Results posted on

2011-04-15

Participant Flow

Participant milestones

Participant milestones
Measure	Ranibizumab Group Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
Overall Study STARTED	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ranibizumab Group Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
Overall Study Protocol Violation	1

Baseline Characteristics

Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ranibizumab Group n=26 Participants Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age Continuous	66.5 years STANDARD_DEVIATION 9.22 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment Thailand	26 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 3 months

Population: Analysis was per protocol

Comparing the response in hight of signal amplitude at 3 months after treatment with baseline data.

Outcome measures

Outcome measures
Measure	Ranibizumab Group n=25 Participants Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
Height (Amplitude) of Multifocal ERG Signal	2.859 nanovolt/degree^2 Standard Deviation 1.085

PRIMARY outcome

Timeframe: baseline, 3 months

Comparing the change in time of signal response (implicit time) at 3 months after treatment with baseline data.

Outcome measures

Outcome measures
Measure	Ranibizumab Group n=26 eyes Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
Time to Response (Implicit Time) of Multifocal ERG Signal	31.621 millisecond Standard Deviation 3.563

SECONDARY outcome

Timeframe: 1 month

For instance, Endophthalmitis, retinal detachment

Outcome measures

Outcome data not reported

Adverse Events

Ranibizumab Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Patama Bhurayanontachai

Prince of Songkla University

Phone: 66-74-451380

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place