Trial Outcomes & Findings for Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion (NCT NCT00406107)

NCT ID: NCT00406107

Last Updated: 2014-09-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 54 Weeks
• Results posted on: 2014-09-12

Participant Flow

Participant milestones

Measure	Pegaptanib Sodium 0.3mg (Macugen)	Pegaptanib Sodium 1 mg (Macugen)
Overall Study STARTED	15	5
Overall Study COMPLETED	14	4
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion

Baseline characteristics by cohort

Measure	Pegaptanib Sodium 0.3mg (Macugen) n=15 Participants Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.	Pegaptanib Sodium 1 mg (Macugen) n=5 Participants Intravitreous injections of Macugen 1.0 mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.	Total n=20 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	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	5 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	72.9 years STANDARD_DEVIATION 8.2 • n=5 Participants	77 years STANDARD_DEVIATION 8.7 • n=7 Participants	73.9 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	5 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 54 Weeks

Outcome measures

Measure	All Study Participants n=20 Participants Outcome measures were assessed without regard to dosage of pegaptanib received	Pegaptanib Sodium 1 mg (Macugen) Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks	14 ETDRS letters Standard Deviation 13	—

SECONDARY outcome

Timeframe: 54 Weeks

Population: Fifteen patients were enrolled in the pegaptanib 0.3 mg dose group and 5 patients were enrolled in the 1.0 mg dose group.

Outcome measures

Measure	All Study Participants n=20 Participants Outcome measures were assessed without regard to dosage of pegaptanib received	Pegaptanib Sodium 1 mg (Macugen) Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield	-205 microns Standard Deviation 195	—

SECONDARY outcome

Timeframe: 54 Weeks

Safety endpoints incuded all investigator reported ocular and systemic adverse events. All events were graded as mild moderate or severe and assessed as related or unrelated to the injection procedure and the study drug.

Outcome measures

Measure	All Study Participants n=15 Participants Outcome measures were assessed without regard to dosage of pegaptanib received	Pegaptanib Sodium 1 mg (Macugen) n=5 Participants Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
Safety Parameters	6.67 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 54 Weeks

Outcome measures

Measure	All Study Participants n=20 Participants Outcome measures were assessed without regard to dosage of pegaptanib received	Pegaptanib Sodium 1 mg (Macugen) Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
Change in Central Subfield Thickness on OCT From Baseline to Week 54	-201 microns Standard Deviation 153	—

SECONDARY outcome

Timeframe: 54 Weeks

Outcome measures

Measure	All Study Participants n=20 Participants Outcome measures were assessed without regard to dosage of pegaptanib received	Pegaptanib Sodium 1 mg (Macugen) Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
Change in Macular Volume on OCT From Baseline to Week 54	-2.2 mm cubed Standard Deviation 1.6	—

Adverse Events

Pegaptanib Sodium 0.3mg (Macugen)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Pegaptanib Sodium 1 mg (Macugen)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pegaptanib Sodium 0.3mg (Macugen) n=15 participants at risk Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.	Pegaptanib Sodium 1 mg (Macugen) n=5 participants at risk Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
Eye disorders retinal detachment	6.7% 1/15 • Number of events 1	0.00% 0/5

Additional Information

John A. Wells, III, M.D.

Palmetto Retina Center

Phone: 803-931-0077

Email: jackwells@palmettoretina.com

Results disclosure agreements

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