NCT00004430

Brief Summary

OBJECTIVES: I. Demonstrate the safety and efficacy of dihematoporphyrin derivative (DHP) in laser photodynamic therapy (PDT) in patients with corneal neovascularization. II. Document the histopathologic mechanism of action in selected patients undergoing penetrating keratoplasty following PDT therapy for corneal neovascularization. III. Facilitate FDA product approval of DHP as a photosensitizing agent for laser treatment in these patients. IV. Explore the use of this photosensitizer for ocular and cutaneous basal cell and squamous cell carcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 1994

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1994

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

March 25, 2015

Status Verified

August 1, 2000

First QC Date

October 18, 1999

Last Update Submit

March 24, 2015

Conditions

Corneal Neovascularization

Keywords

cardiovascular and respiratory diseasescorneal neovascularizationrare disease

Interventions

Dihematoporphyrin derivativeDRUG
prednisoloneDRUG
Laser surgeryPROCEDURE

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Histologically proven corneal neovascularization (CNV): Must have at least 1 quadrant of significant CNV, which is due to bacterial, viral, parasitic, or fungal keratitis; alkaline acid or hydrocarbon chemical burns; ocular trauma and injury; severe ocular surface disease; or previous surgery with complications such as corneal allograft rejection are eligible * No concurrent systemic steroids * No concurrent immunosuppressive therapy * Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; HIV negative; No rheumatoid arthritis; No congenital corneal scars; No active ocular infection or inflammation; No other active systemic collagen vascular disease; No uncontrolled glaucoma; No history of porphyrin allergies; Visual acuity of 20/400 or better in contralateral eye

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (6)

  • Sheppard JD, Chames MA, Clarke KC, et al.: Argon laser photodynamic thrombosis of human corneal neovascularization utilizing intravenous dihematoporphyrin. Investigative Ophthalmology and Visual Science 35(4): 1350, 1994.

    BACKGROUND

  • Chames MA, Sheppard JD, Mittal DC, et al.: A rabbit model for argon laser photodynamic therapy of corneal neovascularization utilizing topical dihematoporphyrin. Investigative Ophthalmology and Visual Science 36(1): 146, 1995.

    BACKGROUND

  • Mittal DC, Chames MS, Sheppard JD, et al.: Distribution of dihematoporphyrin in rabbit cornea, iris, aqueous humor and plasma after topical intravenous administration. Investigative Ophthalmology and Visual Science 36(13): 2564, 1995.

    BACKGROUND

  • Lattanzio F, Rusch A, Sheppard J, et al.: Documentation of corneal neovascularization by quantitative video fluorescein angiography. Investigative Ophthalmology and Visual Science 37: S546, 1996.

    BACKGROUND

  • Cox KW, Sheppard JD, Lattanzio FA, et al.: Photodynamic therapy of corneal neovascularization using topical dihematoporphyrin ester. Investigative Ophthalmology and Visual Science 38: S512, 1997.

    BACKGROUND

  • Williams PB, Sheppard JD, Chames MA, et al.: Distribution of dihematoporphyrin in rabbit cornea, iris, aqueous humor and serum after topical vs intravenous administration. Journal of Clinical Pharmacology 35(10): 936, 1995.

    BACKGROUND

MeSH Terms

Conditions

Corneal NeovascularizationRespiratory Tract DiseasesRare Diseases

Interventions

PrednisoloneLaser Therapy

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • John D. Sheppard

    Eastern Virginia Medical School

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

September 1, 1994

Study Completion

September 1, 1998

Last Updated

March 25, 2015

Record last verified: 2000-08

Locations

US(1)