- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02688309
Pro-permeability and Pro-fibrosis Factors in the Aqueous of Patients With Retinal Diseases (P3F2)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary purpose of this study is to determine the correlation of pro-permeability and pro-fibrosis factor levels and downstream receptor/signaling molecule activation with disease activity in patients with macular edema or fibrosis secondary to any underlying disease.
120 patients will be enrolled from both the clinic and OR, with the latter patients undergoing surgery for proliferative diabetic retinopathy, rhegmatogenous retinal detachment with Proliferative vitreoretinopathy (PVR), rhegmatogenous retinal detachment without PVR, macular pucker, or macular hole. Clinic patients must be receiving an intraocular injection of a steroid as part of standard of care for macular edema or progressive fibrosis.
Surgical patients will receive an anterior chamber (AC) tap at the beginning of surgery, while clinic patients will receive an AC tap prior to the intraocular injection of steroid with a second AC tap at a follow-up visit 6 +/- 2 weeks after the first injection. The aqueous sample will then be analyzed by measuring the levels of various pro-permeability and pro-fibrosis factors and/or their downstream receptor/signaling molecule activation.
We will also determine the correlation between reductions in foveal thickness or improvements in visual acuity with changes in the aqueous levels of pro-permeability and pro-fibrosis factors from baseline to week 6 in the clinic group.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Wilmer Eye Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Signed informed consent and authorization of use and disclosure of protected health information
- Age >= 18 years
- Undergoing surgery as part of standard care for one of the following conditions: (1) Proliferative Diabetic Retinopathy (PDR), (2) rhegmatogenous retinal detachment with PVR, (3) rhegmatogenous retinal detachment without PVR, (4) macular pucker, (5) macular hole OR receiving as part of standard care, an intraocular injection of a steroid for macular edema or progressive fibrosis.
Exclusion Criteria:
- Previous use of an anti-Vascular Endothelial Growth Factor (VEGF) drug within 1 month of study entry
- Any condition that the investigator believes would pose a significant hazard to the subject if standard study procedures were conducted.
- Inability to comply with study or follow up procedures
- Patients with active or suspected ocular or periocular infection, including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- Pregnant patients.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Clinic Patients
Patients from the clinic will be considered for enrollment if they are receiving an intraocular injection of a steroid as part of standard care for macular edema or progressive fibrosis. Clinic patients who are receiving an intraocular injection of steroid (Ozurdex) as part of standard care who agree to participate will have an anterior chamber (AC) tap just prior to the intraocular injection of steroid and a second AC tap at a follow up visit 6 ± 2 weeks after the steroid injection. |
Patients from the clinic will be considered for enrollment if they are receiving an intraocular injection of a steroid as part of standard care for macular edema or progressive fibrosis.
Clinic patients who are receiving an intraocular injection of steroid (Ozurdex) as part of standard care who agree to participate will have an AC tap just prior to the intraocular injection of steroid and a second AC tap at a follow up visit 6 ± 2 weeks after the steroid injection.
Other Names:
A paracentesis removing about 0.1 ml of fluid from the front part of the eye (the aqueous chamber) will be performed in the operating room just prior to surgery or in the clinic.
In the operating room, the AC tap is done after the eye is anesthetized and cleaned with 5% povidone iodine for the surgery.
A 30-gauge needle attached to a tuberculin syringe is inserted into the AC and 0.1 ml of aqueous is removed.
The wound is self-sealing and has no effect on the surgery.
In the clinic, the AC tap is done after drops of proparacaine and 5% povidone iodine is placed in the eye and a lid speculum is inserted.
The patient is seated at a slit lamp and a 30-gauge needle attached to a tuberculin syringe is inserted into the AC and 0.1 ml of aqueous is aspirated and then the needle is removed.
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OR Patients
Patients undergoing surgery for one of the following conditions: (1) Proliferative Diabetic Retinopathy, (2) rhegmatogenous retinal detachment with PVR, (3) rhegmatogenous retinal detachment without PVR, (4) macular pucker, (5) macular hole.
Surgical patients who agree to participate will have an anterior chamber (AC) tap at the beginning of surgery.
|
A paracentesis removing about 0.1 ml of fluid from the front part of the eye (the aqueous chamber) will be performed in the operating room just prior to surgery or in the clinic.
In the operating room, the AC tap is done after the eye is anesthetized and cleaned with 5% povidone iodine for the surgery.
A 30-gauge needle attached to a tuberculin syringe is inserted into the AC and 0.1 ml of aqueous is removed.
The wound is self-sealing and has no effect on the surgery.
In the clinic, the AC tap is done after drops of proparacaine and 5% povidone iodine is placed in the eye and a lid speculum is inserted.
The patient is seated at a slit lamp and a 30-gauge needle attached to a tuberculin syringe is inserted into the AC and 0.1 ml of aqueous is aspirated and then the needle is removed.
The 60 patients from the operating room will be patients undergoing surgery for one of the following conditions: (1) Proliferative Diabetic Retinopathy, (2) rhegmatogenous retinal detachment with PVR, (3) rhegmatogenous retinal detachment without PVR, (4) macular pucker, (5) macula hole.
All patients will be administered an AC (Anterior Chamber) tap just prior to the surgical procedure while in the OR.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation of pro-permeability and pro-fibrosis factor levels and receptor/signaling molecule activation with disease activity.
Time Frame: Baseline
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Correlation between reduction in foveal thickness and changes in aqueous levels of pro-permeability and pro-fibrosis factors from baseline to week 6 in the clinic cohort.
Time Frame: Baseline, week 6.
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Baseline, week 6.
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Correlation between changes in visual acuity and changes in the aqueous levels of pro-permeability and pro-fibrosis factors from baseline to week 6 in the clinic cohort.
Time Frame: Baseline, week 6.
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Baseline, week 6.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Campochiaro, MD, Johns Hopkins University
Publications and helpful links
General Publications
- Scholl S, Kirchhof J, Augustin AJ. Pathophysiology of macular edema. Ophthalmologica. 2010;224 Suppl 1:8-15. doi: 10.1159/000315155. Epub 2010 Aug 18.
- Marmor MF. Mechanisms of fluid accumulation in retinal edema. Doc Ophthalmol. 1999;97(3-4):239-49. doi: 10.1023/a:1002192829817.
- Tranos PG, Wickremasinghe SS, Stangos NT, Topouzis F, Tsinopoulos I, Pavesio CE. Macular edema. Surv Ophthalmol. 2004 Sep-Oct;49(5):470-90. doi: 10.1016/j.survophthal.2004.06.002.
- Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. doi: 10.1056/NEJM199412013312203.
- Vinores SA, Youssri AI, Luna JD, Chen YS, Bhargave S, Vinores MA, Schoenfeld CL, Peng B, Chan CC, LaRochelle W, Green WR, Campochiaro PA. Upregulation of vascular endothelial growth factor in ischemic and non-ischemic human and experimental retinal disease. Histol Histopathol. 1997 Jan;12(1):99-109.
- Lima e Silva R, Shen J, Hackett SF, Kachi S, Akiyama H, Kiuchi K, Yokoi K, Hatara MC, Lauer T, Aslam S, Gong YY, Xiao WH, Khu NH, Thut C, Campochiaro PA. The SDF-1/CXCR4 ligand/receptor pair is an important contributor to several types of ocular neovascularization. FASEB J. 2007 Oct;21(12):3219-30. doi: 10.1096/fj.06-7359com. Epub 2007 May 23.
- Oshima Y, Deering T, Oshima S, Nambu H, Reddy PS, Kaleko M, Connelly S, Hackett SF, Campochiaro PA. Angiopoietin-2 enhances retinal vessel sensitivity to vascular endothelial growth factor. J Cell Physiol. 2004 Jun;199(3):412-7. doi: 10.1002/jcp.10442.
- Campochiaro PA, Hafiz G, Channa R, Shah SM, Nguyen QD, Ying H, Do DV, Zimmer-Galler I, Solomon SD, Sung JU, Syed B. Antagonism of vascular endothelial growth factor for macular edema caused by retinal vein occlusions: two-year outcomes. Ophthalmology. 2010 Dec;117(12):2387-2394.e1-5. doi: 10.1016/j.ophtha.2010.03.060. Epub 2010 Jul 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Eye Diseases
- Retinal Degeneration
- Macular Degeneration
- Fibrosis
- Retinal Diseases
- Macular Edema
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- IRB00045274
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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