Pro-permeability and Pro-fibrosis Factors in the Aqueous of Patients With Retinal Diseases

NCT02688309 | Terminated

• 1 other identifier: IRB00045274
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine potential factors in the aqueous humor that may contribute to the development or progression of macular edema or fibrosis (due to any underlying disease) in patients suffering from these conditions.

Conditions

Macular Edema; Fibrosis of the Retina

Outcome Measures

Primary Outcomes (1)

• Correlation of pro-permeability and pro-fibrosis factor levels and receptor/signaling molecule activation with disease activity.

  Baseline

Secondary Outcomes (2)

• 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.

  Baseline, week 6.

• 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.

  Baseline, week 6.

Study Arms (2)

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.

Drug: Ozurdex; Procedure: Anterior Chamber (AC) Tap

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.

Procedure: Surgery; Procedure: Anterior Chamber (AC) Tap

Interventions

Ozurdex DRUG

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.

Also known as: Dexamethasone intravitreal implant 0.7 mg

Clinic Patients

Surgery PROCEDURE

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.

OR Patients

Anterior Chamber (AC) Tap PROCEDURE

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.

Clinic Patients; OR Patients

Eligibility Criteria

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

Study Population

Proliferative Diabetic Retinopathy, Rhegmatogeous Retinal detachment with and without PVR, Macular pucker, Macular hole, Macular Edema and Fibrosis of the Retina,

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Related Publications (8)

• 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.

  PMID: 20714176 BACKGROUND

• Marmor MF. Mechanisms of fluid accumulation in retinal edema. Doc Ophthalmol. 1999;97(3-4):239-49. doi: 10.1023/a:1002192829817.

  PMID: 10896337 BACKGROUND

• 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.

  PMID: 15325193 BACKGROUND

• 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.

  PMID: 7526212 BACKGROUND

• 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.

  PMID: 9046048 BACKGROUND

• 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.

  PMID: 17522382 BACKGROUND

• 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.

  PMID: 15095288 BACKGROUND

• 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.

  PMID: 20630595 BACKGROUND

MeSH Terms

Conditions

Macular Edema

Interventions

Calcium Dobesilate; Dexamethasone; Surgical Procedures, Operative; Paracentesis

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Investigative Techniques

Study Officials

• Peter Campochiaro, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: February 23, 2016
• Study Start: January 13, 2015
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

US (1)