Trial · NCT01468337
Topical Interferon Gamma-1b for Central Serous Chorioretinopathy
NCT01468337, Phase 1, Phase 2, Completed, National Eye Institute (NEI); results first posted 2014-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Topical Interferon Gamma-1b for Central Serous Chorioretinopathy. Trials, record NCT01468337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01468337
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Interferon Gamma-1b for Central Serous Chorioretinopathy
- NCT number
- NCT01468337
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Eye Institute (NEI)
- Conditions
- Retinal Disease, Macular Disease
- Interventions
- Interferon gamma-1b
- First posted
- 2011-11-09
- Last updated
- 2024-01-30
- Results first posted
- 2014-11-19
- Limitations and caveats
After study completion, a participant presented with a cataract on 4/12/13 (last study dose:10/3/12 and TOTAL study dosage received: 2758 µg). Although age (58) was consistent with the possibility of cataract, relatedness to drug cannot be ruled out.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Number of Severe Ocular Adverse Events Related to the Investigational Product | Week 48 | |
| Primary | Total Number of Ocular Adverse Events Related to Investigational Product | Week 48 | |
| Primary | Total Number of Severe Non-ocular Adverse Events Related to the Investigational Product | Week 48 | |
| Primary | Total Number of Non-ocular Adverse Events Related to the Investigational Product | Week 48 | |
| Primary | Number of Participants Who Withdrew From the Study | Week 48 | |
| Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 2 Compared to Baseline | Baseline and Week 2 | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome. |
| Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 2 Compared to Baseline | Baseline and Week 2 | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome. |
| Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 48 Compared to Baseline | Baseline and Week 48 | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome. |
| Secondary | Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 48 Compared to Baseline | Baseline and Week 48 | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome. |
| Secondary | Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline | Baseline and Week 2 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Number of Severe Ocular Adverse Events Related to the Investigational Product | Week 48 | Adverse Events | NUMBER | |
| PRIMARY | Total Number of Ocular Adverse Events Related to Investigational Product | Week 48 | Adverse Events | NUMBER | |
| PRIMARY | Total Number of Severe Non-ocular Adverse Events Related to the Investigational Product | Week 48 | Adverse Events | NUMBER | |
| PRIMARY | Total Number of Non-ocular Adverse Events Related to the Investigational Product | Week 48 | Adverse Events | NUMBER | |
| PRIMARY | Number of Participants Who Withdrew From the Study | Week 48 | participants | NUMBER | |
| SECONDARY | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 2 Compared to Baseline | Baseline and Week 2 | ETDRS letters | MEAN | |
| SECONDARY | Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 2 Compared to Baseline | Baseline and Week 2 | ETDRS letters | MEAN | |
| SECONDARY | Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 48 Compared to Baseline | Baseline and Week 48 | ETDRS letters | MEAN | |
| SECONDARY | Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 48 Compared to Baseline | Baseline and Week 48 | ETDRS letters | MEAN | |
| SECONDARY | Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline | Baseline and Week 2 | Due to lack of effect in other outcome measures, at investigator's discretion, data for this outcome measure was neither collected nor analyzed. As such, zero participants have data for this outcome. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Number of Severe Ocular Adverse Events Related to the Investigational Product | Interferon Gamma-1b | 0 | Adverse Events | ||
| Total Number of Ocular Adverse Events Related to Investigational Product | Interferon Gamma-1b | 7 | Adverse Events | ||
| Total Number of Severe Non-ocular Adverse Events Related to the Investigational Product | Interferon Gamma-1b | 0 | Adverse Events | ||
| Total Number of Non-ocular Adverse Events Related to the Investigational Product | Interferon Gamma-1b | 0 | Adverse Events | ||
| Number of Participants Who Withdrew From the Study | Interferon Gamma-1b | 0 | participants | ||
| Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 2 Compared to Baseline | Interferon Gamma-1b | 0.4 | Full Range -3.00 to 5.00 | ETDRS letters | |
| Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 2 Compared to Baseline | Interferon Gamma-1b | 0.80 | Full Range -2.00 to 7.00 | ETDRS letters | |
| Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 48 Compared to Baseline | Interferon Gamma-1b | 2.67 | Full Range -3.00 to 13.00 | ETDRS letters | |
| Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 48 Compared to Baseline | Interferon Gamma-1b | 4.67 | Full Range 1.00 to 9.00 | ETDRS letters |
Source ClinicalTrials.gov
Participant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Interferon Gamma-1b | 5 | |
| Overall Study | Week 2 | Interferon Gamma-1b | 5 | |
| Overall Study | Received Interferon Gamma-1b at Week 4 | Interferon Gamma-1b | 2 | |
| Overall Study | Received Interferon Gamma-1b After Wk 8 | Interferon Gamma-1b | 4 | |
| Overall Study | Week 48 | Interferon Gamma-1b | 3 | |
| Overall Study | COMPLETED | Interferon Gamma-1b | 5 | |
| Overall Study | NOT COMPLETED | Interferon Gamma-1b | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthenopia | Eye disorders | Interferon Gamma-1b | 1 | 5 | 2 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Interferon Gamma-1b | 1 | 5 | 1 |
| other | Burning sensation | Nervous system disorders | Interferon Gamma-1b | 1 | 5 | 1 |
| other | Conjunctival hyperaemia | Eye disorders | Interferon Gamma-1b | 3 | 5 | 5 |
| other | Eye pruritis | Eye disorders | Interferon Gamma-1b | 2 | 5 | 2 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Interferon Gamma-1b | 1 | 5 | 1 |
| other | Ocular hyperaemia | Eye disorders | Interferon Gamma-1b | 2 | 5 | 2 |
| other | Ocular hypertension | Eye disorders | Interferon Gamma-1b | 1 | 5 | 2 |
| other | Periorbital oedema | Eye disorders | Interferon Gamma-1b | 1 | 5 | 1 |
| other | Prostate infection | Infections and infestations | Interferon Gamma-1b | 1 | 5 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Interferon Gamma-1b | ||
| Total, other adverse events | Interferon Gamma-1b | 5 | 5 |
| Total, serious adverse events | Interferon Gamma-1b | 0 | 5 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01468337
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