Microplasmin Intravitreal Administration in Participants With Uveitic Macular Edema

NCT01194674 | Terminated Phase 1 Results

• 2 other identifiers: 10018610-EI-0186
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the safety and efficacy of microplasmin as a treatment for uveitic macular edema.

Conditions

Uveitis

Keywords

Microplasmin; Macular Edema; Uveitis

Outcome Measures

Primary Outcomes (4)

• Number of Adverse Events

  24 weeks

• Number of Severe Adverse Events

  24 weeks

• Number of Ocular Adverse Events

  The number of eye-related adverse events was calculated.

  24 weeks

• Number of Non-ocular Adverse Events

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

  24 weeks

Secondary Outcomes (5)

• Change in Central Macular Thickness, as Measured by Optical Coherence Tomography (OCT), at 4 Weeks vs. Baseline

  Baseline and 4 weeks

• Number of Participants Achieving Macular or Complete Posterior Vitreous Detachment (PVT) at 4 Weeks

  Baseline and 4 weeks

• Change in ETDRS Best-corrected Visual Acuity (BCVA) at 4 Weeks vs. Baseline

  Baseline and 4 weeks

• Change in ETDRS Best-corrected Visual Acuity (BCVA) at 12 Weeks vs. Baseline

  Baseline and 12 Weeks

• Change in Retino-vascular Leakage, as Seen on Fluorescein Angiography (FA), at 4 Weeks vs. Baseline

  Baseline and 4 weeks

Study Arms (1)

Microplasmin

EXPERIMENTAL

Drug: Microplasmin

Interventions

Microplasmin DRUG

Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.

Microplasmin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 years of age or older.
• Participant must understand and sign the protocol's informed consent document.
• Participant has a diagnosis of uveitic macular edema that requires treatment in at least one eye (the study eye) and the uveitis in the study eye is deemed clinically quiet by the investigator.
• Participant has no evidence of macular or complete PVD in the study eye by B-scan ultrasound and OCT.
• Participant has visual acuity of 20/400 or better in the study eye.
• Participant has a central macular thickness ≥ 270 microns in the study eye and loss of the normal foveal contour.
• Participant does not have significant cataract or media opacity in the study eye that makes posterior segment visualization difficult as determined by investigator.
• Female participants of childbearing potential must not be pregnant or breast-feeding and must have a negative serum pregnancy test at screening and throughout the study.
• Both female participants of childbearing potential and male participants able to father a child must agree to practice two effective methods of birth control for six months following administration of study medication. Acceptable methods of birth control for this study include hormonal contraception (birth control pills, injected hormones, dermal patch or vaginal ring), intrauterine device, barrier methods (diaphragm, condom) with spermicide or surgical sterilization (hysterectomy, tubal ligation or vasectomy). Participants with a hysterectomy or vasectomy (or have a partner with a hysterectomy or vasectomy) are exempt from using two methods of birth control.
• Participant is willing to comply with the study procedures and return for all study visits.

You may not qualify if:

• Participant has uncontrolled glaucoma, defined as intraocular pressure \>30 mmHg despite treatment with anti-glaucoma medication, in the study eye.
• Participant has lattice degeneration of the retina in the study eye deemed to be high risk by the investigator.
• Participant has untreated retinal holes or tears, or a macular hole in the study eye.
• Participant has a significant active ocular infection in the study eye.
• Participant had intraocular surgery within the past 90 days or anticipates elective intraocular surgery in the study eye.
• Participant had an injection of bevacizumab or ranibizumab within the past four weeks in the study eye.
• Participant had an injection of triamcinolone within the past six weeks in the study eye.
• Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status that would pose a significant hazard if investigational therapy was started).
• Participant has known anaphylaxis to sodium fluoride, or has urticaria, angioedema or an anaphylactoid response to sodium fluorescein dye that cannot be safely pre-medicated with an antihistamine and/or prednisone.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Gritz DC, Wong IG. Incidence and prevalence of uveitis in Northern California; the Northern California Epidemiology of Uveitis Study. Ophthalmology. 2004 Mar;111(3):491-500; discussion 500. doi: 10.1016/j.ophtha.2003.06.014.

  PMID: 15019324 BACKGROUND

• Djalilian AR, Nussenblatt RB. Immunosuppression in uveitis. Ophthalmol Clin North Am. 2002 Sep;15(3):395-404, viii. doi: 10.1016/s0896-1549(02)00036-6.

  PMID: 12434489 BACKGROUND

• Whitcup SM, Hikita N, Shirao M, Miyasaka M, Tamatani T, Mochizuki M, Nussenblatt RB, Chan CC. Monoclonal antibodies against CD54 (ICAM-1) and CD11a (LFA-1) prevent and inhibit endotoxin-induced uveitis. Exp Eye Res. 1995 Jun;60(6):597-601. doi: 10.1016/s0014-4835(05)80001-6.

  PMID: 7641842 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Uveitis; Macular Edema

Interventions

microplasmin

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Limitations and Caveats

The study was terminated early due to lack of enrollment.

Results Point of Contact

• Title: H. Nida Sen, Principal Investigator, National Eye Institute
• Organization: National Institutes of Health

senh@nei.nih.gov

301-402-3254

Study Officials

• Hatice Nida Sen, MD, MHSc

  National Institutes of Health (NIH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, NEI

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 3, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 31, 2018
• Results First Posted: August 14, 2012

Record last verified: 2018-07

Locations

US (1)