Trial Outcomes & Findings for Safety of 16.5 mg (3.3%) CGC-11047 Once Every 2 Weeks vs. Once Every 4 Weeks in Patients With CNV Due to AMD (NCT NCT00446654)

Last Updated: 2012-08-06

Results Overview

Visual acuity was measured with a standard eye exam using the preferred research based eye chart (LogMar chart). On the LogMar chart each letter has a score value of 0.02 log units. LogMAR VA = 0.1 + LogMAR value of the best line read - 0.02 X (number of letters read). The outcome measure presented is the difference in LogMAR between baseline and at three months.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

43 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2012-08-06

Participant Flow

The recruitment period spanned 05 February 2007 to 10 July 2007. Patients were randomised to one of the two treatment groups. Treatment group assignment for each patient was made centrally.

Participant milestones

Participant milestones
Measure	CGC-11047 Once Every 2 Weeks 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.	CGC-11047 Once Every Four Weeks 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
Overall Study STARTED	21	22
Overall Study COMPLETED	19	22
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CGC-11047 Once Every 2 Weeks 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.	CGC-11047 Once Every Four Weeks 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
Overall Study Withdrawal by Subject	1	0
Overall Study Adverse Event	1	0

Baseline Characteristics

Safety of 16.5 mg (3.3%) CGC-11047 Once Every 2 Weeks vs. Once Every 4 Weeks in Patients With CNV Due to AMD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CGC-11047 Once Every 2 Weeks n=21 Participants 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.	CGC-11047 Once Every Four Weeks n=22 Participants 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.	Total n=43 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	7 participants n=5 Participants	3 participants n=7 Participants	10 participants n=5 Participants
Age Categorical >=65 years	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants
Age Continuous	69.3 years STANDARD_DEVIATION 8.5 • n=5 Participants	68.1 years STANDARD_DEVIATION 7.0 • n=7 Participants	68.7 years STANDARD_DEVIATION 7.7 • n=5 Participants
Gender Female	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Gender Male	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Mexico	5 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Russian Federation	14 participants n=5 Participants	20 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: Analysis was performed on all patients who received at least one treatment.

Outcome measures

Outcome measures
Measure	CGC-11047 Once Every 2 Weeks n=21 Participants 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.	CGC-11047 Once Every Four Weeks n=21 Participants 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
Change in Baseline to 3 Months in Best Corrected Visual Acuity	-0.01 logMAR Standard Deviation 0.21	0.08 logMAR Standard Deviation 0.25

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

Adverse Events

CGC-11047 Once Every 2 Weeks

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

CGC-11047 Once Every Four Weeks

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CGC-11047 Once Every 2 Weeks n=21 participants at risk 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.	CGC-11047 Once Every Four Weeks n=22 participants at risk 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
Gastrointestinal disorders Strangulate umbilical hernia	4.8% 1/21 • Number of events 1 • 3 months	0.00% 0/22 • 3 months
Eye disorders Loss of visual acuity	4.8% 1/21 • Number of events 1 • 3 months	0.00% 0/22 • 3 months

Other adverse events

Other adverse events
Measure	CGC-11047 Once Every 2 Weeks n=21 participants at risk 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.	CGC-11047 Once Every Four Weeks n=22 participants at risk 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
Eye disorders Conjunctival haemorrhage	9.5% 2/21 • Number of events 4 • 3 months	4.5% 1/22 • Number of events 1 • 3 months
Eye disorders Eye pain	28.6% 6/21 • Number of events 12 • 3 months	4.5% 1/22 • Number of events 1 • 3 months
Eye disorders Foreign body sensation in eye	9.5% 2/21 • Number of events 5 • 3 months	0.00% 0/22 • 3 months
General disorders Injection site pain	14.3% 3/21 • Number of events 3 • 3 months	0.00% 0/22 • 3 months
General disorders Pain	4.8% 1/21 • Number of events 3 • 3 months	4.5% 1/22 • Number of events 1 • 3 months

Additional Information

Director of Clinical Trials

Progen Pharmacauticals Ltd

Phone: +61 7 32739133

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place