Ignite Creation Date:
2024-05-06 @ 12:01 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01468337
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2011-11-05
Brief Title:
Topical Interferon Gamma-1b for Central Serous Chorioretinopathy
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Phase III Study of the Treatment of Classic Central Serous Chorioretinopathy With Topical Interferon Gamma-1b
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- In the eye disease central serous chorioretinopathy CSC fluid collects under the retina at the back of the eye CSC can resolve on its own but in some people it lasts for several months or can come back The fluid buildup during CSC can cause vision loss The drug interferon gamma-1b can help reduce fluid accumulation in the retina Researchers want to see if interferon gamma-1b can help treat and prevent vision loss from CSC
Objectives
- To see if interferon gamma-1b eye drops are a safe and effective treatment for CSC
Eligibility
- Individuals at least 18 years of age who have CSC in at least one eye
Design
Participants will be screened with a physical exam and medical history They will also have an eye exam and blood tests
This study will require at least ten visits to the National Institutes of Health eye clinic over a total of 52 weeks one year Most visits will last up to 4 hours
Participants will return to the eye clinic 2 days after the first visit and 1 2 4 8 12 24 36 and 48 weeks after starting the study eye drops These visits will involve blood tests and eye exams
Participants will receive the study eye drops at the initial visit The drops must be used three or four times a day for 2 weeks They must be stored in a cool place like a refrigerator The doses will follow an escalation schedule with the first participant receiving 2 drops three times a day and the last participant receiving 4 drops four times a day To maximize safety the most-recently enrolled participant will complete Week 4 before the next participant can enroll eg the second enrolled participant will not be enrolled until the first has completed the Week 4 visit
If the CSC does not improve after the first 2 weeks participants will receive another 2 weeks of eye drops This set of drops will start 4 weeks after the initial study visit
If the CSC does not improve after the 8-week study period participants may receive additional eye drops at the maximum dose of 4 drops four times daily
The study will end for each participant at one year 48 weeks after the initial study visit
- In the eye disease central serous chorioretinopathy CSC fluid collects under the retina at the back of the eye CSC can resolve on its own but in some people it lasts for several months or can come back The fluid buildup during CSC can cause vision loss The drug interferon gamma-1b can help reduce fluid accumulation in the retina Researchers want to see if interferon gamma-1b can help treat and prevent vision loss from CSC
Objectives
- To see if interferon gamma-1b eye drops are a safe and effective treatment for CSC
Eligibility
- Individuals at least 18 years of age who have CSC in at least one eye
Design
Participants will be screened with a physical exam and medical history They will also have an eye exam and blood tests
This study will require at least ten visits to the National Institutes of Health eye clinic over a total of 52 weeks one year Most visits will last up to 4 hours
Participants will return to the eye clinic 2 days after the first visit and 1 2 4 8 12 24 36 and 48 weeks after starting the study eye drops These visits will involve blood tests and eye exams
Participants will receive the study eye drops at the initial visit The drops must be used three or four times a day for 2 weeks They must be stored in a cool place like a refrigerator The doses will follow an escalation schedule with the first participant receiving 2 drops three times a day and the last participant receiving 4 drops four times a day To maximize safety the most-recently enrolled participant will complete Week 4 before the next participant can enroll eg the second enrolled participant will not be enrolled until the first has completed the Week 4 visit
If the CSC does not improve after the first 2 weeks participants will receive another 2 weeks of eye drops This set of drops will start 4 weeks after the initial study visit
If the CSC does not improve after the 8-week study period participants may receive additional eye drops at the maximum dose of 4 drops four times daily
The study will end for each participant at one year 48 weeks after the initial study visit
Detailed Description:
Objective Central serous chorioretinopathy CSC is a retinal disorder characterized by an accumulation of serous fluid under the retina thought to be due to excessive choroidal hyperpermeability The retinal pigment epithelium RPE plays a critical role in removing fluid from the subretinal space This RPE pump is believed to be a key player in the reabsorption of subretinal fluid and maintenance of retinal attachment Fluid transport assays have examined whether interferon gamma induces changes in fluid transport across human fetal RPE monolayers and showed an increase in fluid absorption from the retinal to the choroidal side of the tissue An in vivo rodent model of retinal detachment has been used to measure the effect of interferon gamma on re-absorption following retinal detachment and showed that the addition of interferon gamma to the anterior eye surface caused a significant rapid decrease in retinal detachment volume in the first hour of observation This pilot study will investigate the safety tolerability and potential efficacy of serial ocular instillations of topical interferon gamma-1b for classic CSC
Study Population Five participants with subretinal fluid due to classic CSC will initially be enrolled However up to an additional two participants may be enrolled in order to obtain the five participants to be included in the analysis if any participants withdraw from the study
Design In this Phase III non-randomized prospective uncontrolled dose-escalation single-center pilot study a series of ocular instillations of topical interferon gamma-1b will be administered in the study eye over a two-week period If the fluid re-accumulates or increases participants will be eligible for re-challenging with topical interferon gamma-1b in the study eye at Week 4 Participants will be followed for one year Participants may be eligible for additional re-challenges after the initial eight week study period ends if their fluid re-accumulates or increases further
Outcome Measures The primary outcome measure related to the safety and tolerability of serial ocular instillations of topical interferon gamma-1b will be assessed by the number and severity of adverse events AEs related to the investigational product and the number of withdrawals Secondary efficacy outcomes include changes in best-corrected visual acuity BCVA central retinal thickness and maximum lesion volume as measured on optical coherence tomography OCT leakage as observed on fluorescein angiograms FA autofluorescence patterns as observed on fundus autofluorescence FAF imaging and mean macular sensitivity as assessed by microperimetry
Study Population Five participants with subretinal fluid due to classic CSC will initially be enrolled However up to an additional two participants may be enrolled in order to obtain the five participants to be included in the analysis if any participants withdraw from the study
Design In this Phase III non-randomized prospective uncontrolled dose-escalation single-center pilot study a series of ocular instillations of topical interferon gamma-1b will be administered in the study eye over a two-week period If the fluid re-accumulates or increases participants will be eligible for re-challenging with topical interferon gamma-1b in the study eye at Week 4 Participants will be followed for one year Participants may be eligible for additional re-challenges after the initial eight week study period ends if their fluid re-accumulates or increases further
Outcome Measures The primary outcome measure related to the safety and tolerability of serial ocular instillations of topical interferon gamma-1b will be assessed by the number and severity of adverse events AEs related to the investigational product and the number of withdrawals Secondary efficacy outcomes include changes in best-corrected visual acuity BCVA central retinal thickness and maximum lesion volume as measured on optical coherence tomography OCT leakage as observed on fluorescein angiograms FA autofluorescence patterns as observed on fundus autofluorescence FAF imaging and mean macular sensitivity as assessed by microperimetry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-EI-0013 | None | None | None |