Trial Outcomes & Findings for Microplasmin Intravitreal Administration in Participants With Uveitic Macular Edema (NCT NCT01194674)

NCT ID: NCT01194674

Last Updated: 2018-07-31

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2018-07-31

Participant Flow

Participant milestones

Measure	Microplasmin Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Microplasmin Intravitreal Administration in Participants With Uveitic Macular Edema

Baseline characteristics by cohort

Measure	Microplasmin n=2 Participants Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	40.50 years FULL_RANGE 17.68 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Microplasmin n=2 Participants Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Number of Adverse Events	4 Adverse Events

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Microplasmin n=2 Participants Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Number of Severe Adverse Events	0 Adverse Events

PRIMARY outcome

Timeframe: 24 weeks

The number of eye-related adverse events was calculated.

Outcome measures

Measure	Microplasmin n=2 Participants Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Number of Ocular Adverse Events	1 Adverse Events

PRIMARY outcome

Timeframe: 24 weeks

The number of adverse events that were not eye-related was calculated.

Outcome measures

Measure	Microplasmin n=2 Participants Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Number of Non-ocular Adverse Events	3 Adverse Events

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.

Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.

This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 Weeks

Population: This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.

Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: This protocol terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.

Retino-vascular leakage was calculated after manually outlining the inner and outer borders of the subretinal fluid packet in the optical coherence tomography (OCT) images using the "Edit Segmentation" function of the Cirrus HD-OCT software. For cases in which a pigment epithelial detachment was present, the volume of the pigment epithelial detachment was included in the calculation of leakage volume. This study terminated early due to lack of recruitment; therefore, we chose not to report due to insufficient data.

Outcome measures

Outcome data not reported

Adverse Events

Microplasmin

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Microplasmin n=2 participants at risk Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 1/2 • Number of events 1 • 24 weeks
Investigations Blood glucose increased	50.0% 1/2 • Number of events 1 • 24 weeks
Infections and infestations Conjunctivitis infective	50.0% 1/2 • Number of events 1 • 24 weeks
Skin and subcutaneous tissue disorders Rash	50.0% 1/2 • Number of events 1 • 24 weeks

Additional Information

H. Nida Sen, Principal Investigator, National Eye Institute

National Institutes of Health

Phone: 301-402-3254

Email: senh@nei.nih.gov

Results disclosure agreements

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