Macular EdemaP3F2NCT02688309
Pro-permeability and Pro-fibrosis Factors in the Aqueous of Patients With Retinal Diseases
An observational study of Macular Edema and Fibrosis of the Retina, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Fibrosis of the Retina
- What is being tested?
- Ozurdex, Surgery and Anterior Chamber (AC) Tap
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2015to 28 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Proliferative Diabetic Retinopathy, Rhegmatogeous Retinal detachment with and without PVR, Macular pucker, Macular hole, Macular Edema and Fibrosis of the Retina,
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Macular Edema, Fibrosis of the Retina
- Being tested
- Ozurdex, Surgery, Anterior Chamber (AC) Tap
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzurdexDrug
Also called Dexamethasone intravitreal implant 0.7 mg
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.
SurgeryProcedure or surgery
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.
Anterior Chamber (AC) TapProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Surgery; Procedure: Anterior Chamber (AC) Tap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of pro-permeability and pro-fibrosis factor levels and receptor/signaling molecule activation with disease activity.
Measured: 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.
Measured: 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.
Measured: Baseline, week 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start13 Jan 2015
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Why it stopped: Enrollment was affected due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Campochiaro, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688309
- Sponsor's protocol ID
- IRB00045274
- Acronym
- P3F2
- Status last verified
- Jul 2022
- First submitted
- 21 Dec 2015
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20714176Marmor MF. Mechanisms of fluid accumulation in retinal edema. Doc Ophthalmol. 1999;97(3-4):239-49. doi: 10.1023/a:1002192829817.
PubMed 10896337Tranos 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.
PubMed 15325193Aiello 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.
PubMed 7526212Vinores 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.
PubMed 9046048Lima 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.
PubMed 17522382Oshima 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.
PubMed 15095288Campochiaro 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.
PubMed 20630595
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pro-permeability and Pro-fibrosis Factors in the Aqueous of Patients With Retinal Diseases
- ClinicalTrials.gov ID
- NCT02688309
- Acronym / sponsor ID
- P3F2 / IRB00045274
- Conditions
- Macular Edema, Fibrosis of the Retina
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment was affected due to the COVID-19 pandemic
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 13 Jan 2015 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic Patients | – | Drug: Ozurdex, Procedure: Anterior Chamber (AC) TapPatients 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. |
| OR Patients | – | Procedure: Surgery, Procedure: Anterior Chamber (AC) TapPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Proliferative Diabetic Retinopathy, Rhegmatogeous Retinal detachment with and without PVR, Macular pucker, Macular hole, Macular Edema and Fibrosis of the Retina,
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OzurdexAlso: Dexamethasone intravitreal implant 0.7 mgPatients 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. | Drug | Clinic Patients |
| SurgeryThe 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. | Procedure or surgery | OR Patients |
| Anterior Chamber (AC) TapA 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. | Procedure or surgery | Clinic Patients, OR Patients |
Primary outcome
Correlation of pro-permeability and pro-fibrosis factor levels and receptor/signaling molecule activation with disease activity.
Time frame: Baseline
2 secondary outcomes
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.
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.
Results and safety
The study was stopped early (reason given: Enrollment was affected due to the COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Background: PubMed 20714176Scholl S, Kirchhof J, Augustin AJ. Pathophysiology of macular edema. Ophthalmologica. 2010;224 Suppl 1:8-15. doi: 10.1159/000315155. Epub 2010 Aug 18.
- Background: PubMed 10896337Marmor MF. Mechanisms of fluid accumulation in retinal edema. Doc Ophthalmol. 1999;97(3-4):239-49. doi: 10.1023/a:1002192829817.
- Background: PubMed 15325193Tranos 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.
- Background: PubMed 7526212Aiello 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.
- Background: PubMed 9046048Vinores 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.
- Background: PubMed 17522382Lima 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.
- Background: PubMed 15095288Oshima 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.
- Background: PubMed 20630595Campochiaro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Campochiaro, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema and Fibrosis of the Retina, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment was affected due to the COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of pro-permeability and pro-fibrosis factor levels and receptor/signaling molecule activation with disease activity. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02688309, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.