Trial · NCT01526889
Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,
NCT01526889, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2018-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,. Trials, record NCT01526889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01526889
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety,Tolerability and Efficacy of Intravitreal LFG316 in Patients With Active Non-infectious Intermediate-, posterior-or Panuveitis ,
- NCT number
- NCT01526889
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Panuveitis
- Interventions
- LFG316, Conventional Therapy
- First posted
- 2012-02-06
- Last updated
- 2021-01-05
- Other registries' IDs
- eudract:2011-003254-90
- Results first posted
- 2018-10-31
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Day 85 (end of study) | Response rate as defined by: 1. An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR 2. An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR 3. An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR 4. Absence of chorioretinal lesions as determined by the investigator |
| Primary | Number of Participants With Remission in Study Eye - Treatment Period | Day 85 (end of study) | Remission (complete response) was defined as any patient who had: * a vitreous haze score of 0 or 0.5 (scale of 0 to 4) in the study eye, AND * an anterior chamber cell score of 0 (scale of 0 to 4), AND * no chorioretinal lesions in the study eye, AND * was off all immune modulatory therapy (systemic, corticosteroids and topical), AND * without any worsening of uveitis during the trial. |
| Secondary | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | Vitreous haze score (based on funduscopic exam): 0, 0.5/Trace, 1+, 2+, 3+, 4+ Vitreous haze score (scale of 0 to 4) with a score of 4 being the most hazed. |
| Secondary | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions. ETDRS best-corrected visual acuity was obtained in each eye separately under certified ETDRS conditions. This assessment was to be performed prior to pupil dilation. The number of letters read correctly (for each eye) was recorded. BCVA is based on the number of letters read correctly. |
| Secondary | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 85 (end of study) | Macular edema is a sign of uveitis. |
| Secondary | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | Chorioretinal lesions is a sign of uveitis. |
| Secondary | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | anterior chamber cells score (ACCS) with the scores being 0 (≤ 1 cell), 0.5 (1 to 5 aqueous cells), 1 (6 to 15 aqueous cells), 2 (16 to 25 aqueous cells), 3 (26 to 50 aqueous cells), 4 (\>50 aqueous cells). |
| Secondary | Number of Participants With or Without Anti-LFG316 Antibodies | Throughout the study (treatment and extension period), up to day 271 | Blood will be collected at each visit for the profiling of serum drug concentrations. The summary of immunogenicity (IG) by visit . The immunogenicity data (presence/absence of anti-LFG316 antibodies \[anti-drug antibodies\]). NO: No immunogenicity; YES: Positive immunogenicity. |
| Secondary | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 2, 15, 29, 43, 57 and, 85 (end of the study) | Percent change from baseline (using each patient's pre-dose value as baseline) in total C5 concentrations. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Day 85 (end of study) | Efficacy 1 analysis set: All patients in the safety analysis set who received any study treatment (LFG316 or conventional treatment) with evaluable efficacy data for at least one efficacy endpoint(s) (ocular assessments) and with no major protocol deviations that had an impact on efficacy data. | Participants | NUMBER |
| PRIMARY | Number of Participants With Remission in Study Eye - Treatment Period | Day 85 (end of study) | Efficacy 1 analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | Efficacy 1 analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | Efficacy 1 analysis set | letters | MEAN |
| SECONDARY | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 85 (end of study) | Efficacy 1 analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | Efficacy 1 analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | Efficacy 1 analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With or Without Anti-LFG316 Antibodies | Throughout the study (treatment and extension period), up to day 271 | Pharmacokinetic analysis set: All patients in the safety analysis set with evaluable PK data and with no protocol deviations affecting PK data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 2, 15, 29, 43, 57 and, 85 (end of the study) | Pharmacodynamic (PD) analysis set: All patients in the safety analysis set with EVALUABLE pharmacodynamics (PD) data (Total C5) and with no major protocol deviations that had an impact on PD data were included in the PD analysis set. | Percent change in C5 | MEAN |
Source ClinicalTrials.gov
Results by group243
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | LFG316 | Improvement of vitreous haze ≥2 steps (N=15,6) | 3 | Participants | |
| Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Conventional Therapy | Improvement of vitreous haze ≥2 steps (N=15,6) | 3 | Participants | |
| Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | LFG316 | Improvement of VA ≥ 10 letters (N=15,6) | 0 | Participants | |
| Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Conventional Therapy | Improvement of VA ≥ 10 letters (N=15,6) | 1 | Participants | |
| Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | LFG316 | Improvement of ACC score ≥2 steps (N=7, 1) | 0 | Participants | |
| Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Conventional Therapy | Improvement of ACC score ≥2 steps (N=7, 1) | 0 | Participants | |
| Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | LFG316 | Resolution of chorioretinal lesions (N= 3, 0) | 0 | Participants | |
| Number of Participants With Remission in Study Eye - Treatment Period | LFG316 | 2 | Participants | ||
| Number of Participants With Remission in Study Eye - Treatment Period | Conventional Therapy | 0 | Participants | ||
| Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | LFG316 | Day 2 / 0 | 0 | Participants |
1 to 10 of 243Source ClinicalTrials.gov
See all 243 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | LFG316 | 18 | |
| Treatment Period | STARTED | Conventional Therapy | 7 | |
| Treatment Period | COMPLETED | LFG316 | 16 | |
| Treatment Period | COMPLETED | Conventional Therapy | 7 | |
| Treatment Period | NOT COMPLETED | LFG316 | 2 | |
| Treatment Period | NOT COMPLETED | Conventional Therapy | 0 | |
| Treatment Extension Period | STARTED | LFG316 | 5 | |
| Treatment Extension Period | STARTED | Conventional Therapy | 0 | |
| Treatment Extension Period | COMPLETED | LFG316 | 4 | |
| Treatment Extension Period | COMPLETED | Conventional Therapy | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events62
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 | Cataract | Eye disorders | LFG316 | 1 | 18 | |
| other | Cataract | Eye disorders | Conventional Therapy | 0 | 7 | |
| other | Conjunctival haemorrhage | Eye disorders | LFG316 | 4 | 18 | |
| other | Conjunctival haemorrhage | Eye disorders | Conventional Therapy | 0 | 7 | |
| other | Conjunctival hyperaemia | Eye disorders | LFG316 | 1 | 18 | |
| other | Conjunctival hyperaemia | Eye disorders | Conventional Therapy | 0 | 7 | |
| other | Cystoid macular oedema | Eye disorders | LFG316 | 1 | 18 | |
| other | Cystoid macular oedema | Eye disorders | Conventional Therapy | 0 | 7 | |
| other | Dry eye | Eye disorders | LFG316 | 1 | 18 | |
| other | Dry eye | Eye disorders | Conventional Therapy | 1 | 7 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LFG316 | 0 | 18 |
| Total, all-cause mortality | Conventional Therapy | 0 | 7 |
| Total, other adverse events | LFG316 | 11 | 18 |
| Total, other adverse events | Conventional Therapy | 5 | 7 |
| Total, serious adverse events | LFG316 | 1 | 18 |
| Total, serious adverse events | Conventional Therapy | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LFG316 vs Conventional Therapy: Number of Participants With Remission in Study Eye - Treatment Period | Trial comparisons |
| LFG316 vs Conventional Therapy: deaths from any cause | Trial comparisons |
| LFG316 vs Conventional Therapy: serious adverse events | Trial comparisons |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01526889
GET https://conductscience.org/api/trials/v1/NCT01526889/results?page=2