Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613919
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Six-months Versus Nine-months ATT for Ocular TB
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Randomised Trial for 6-Months Versus 9-Months Anti-TB Therapy for Tubercular Posterior Uveitis
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if 6-months anti-TB therapy is not worse than 9-months therapy for the treatment of tubercular posterior uveitis The main questions it aims to answer are
Does six-month therapy work as well as the nine-month therapy Do any of the specific phenotypes of TB posterior uveitis respond better to any specific duration of anti-TB therapy
Participants
Took the standard dose of six- or nine-month ATT for TB posterior uveitis Visit the clinic as advised for checkups and tests
Does six-month therapy work as well as the nine-month therapy Do any of the specific phenotypes of TB posterior uveitis respond better to any specific duration of anti-TB therapy
Participants
Took the standard dose of six- or nine-month ATT for TB posterior uveitis Visit the clinic as advised for checkups and tests
Detailed Description:
1 Tubercular uveitis TBU is a major cause of intraocular inflammation in TB-endemic countries It has several clinical manifestations affecting nearly every tissue in the eye Histopathological studies of TBU have revealed presence of paucibacillary mycobacterial infection and granulomatous infection in enucleated eyes Unlike TB in other organ systems microbiological evidence of TB is rarely found in ocular fluids that are sampled from TBU eyes Hence the diagnosis of TBU is based on presence of characteristic clinical signs ancillary evidence of systemic TB infection and exclusion of non-TB entities Active pulmonary TB however is rarely found in TBU patients
2 While there are no agreed management guidelines for TBU several studies both from TB-endemic and non-endemic countries have supported the utility of anti-TB therapy ATT in the resolution of ocular inflammation and prevention of recurrence Delay in initiation of ATT has led to chronic inflammation and prolonged visual impairment in TBU 6 These studies have typically been retrospective and have included patients with wide range of clinical presentations based on diagnostic criteria described above Majority of these studies have used adjunctive corticosteroids andor immunosuppressants along with ATT The duration of ATT in these studies have varied from 6-24 months A meta-analysis of these studies revealed that 84 95 CI 79-89 of the patients receiving ATT had no recurrence of inflammation during the follow-up period
AIM of the study To compare the efficacy of 6-month with that of 9-month ATT for the treatment of clinically diagnosed tubercular posterior uveitis TPU
Study design An international multicenter prospective randomized observer masked-study in three centres spread across India Myanmar and Thailand
Patient assesment This included detailed history of ocular and systemic illnesses history of TB contact in past ETDRS best corrected visual acuity converted from Snellens if ETDRS unavailable intraocular pressure by Goldmann applanation tonometry slit lamp biomicroscopy and indirect ophthalmoscopy Fundus photography seven-field or wide-field if available was performed for all patients Other ocular imaging such as fluorescien angiography fundus autofluorescence optical coherence tomography OCT OCT-angiography or indocyanine green angiography were performed as per specific requirements in individual cases All patients with clinical signs compatible with TPU were investigated for complete blood counts erythrocyte sedimentation rate HIV VDRL TST and contrast enhanced computed tomography CECT of thorax If CECT is not available at a centre then a digital X-ray of the chest was considered in lieu of it IGRA was performed in conjunction with TST or in patients with strong suspicion of TPU but negative TST Additional investigations were performed at the discretion of the investigator to rule out non-TB diagnosis
Follow-up evaluation were done at 2 weeks 1 month -1 week 2 months -2 weeks 4 months -2 weeks 6 months -4 weeks 9 months -4weeks and then 3 monthly -4 weeks till one year after completion of ATT The one-year cut-off limit has been chosen since most recurrences have been known to occur within one year after the completion of ATT at least in case of pulmonary TB Ocular and systemic evaluation including ocular imaging as described above will be performed for each visit
2 While there are no agreed management guidelines for TBU several studies both from TB-endemic and non-endemic countries have supported the utility of anti-TB therapy ATT in the resolution of ocular inflammation and prevention of recurrence Delay in initiation of ATT has led to chronic inflammation and prolonged visual impairment in TBU 6 These studies have typically been retrospective and have included patients with wide range of clinical presentations based on diagnostic criteria described above Majority of these studies have used adjunctive corticosteroids andor immunosuppressants along with ATT The duration of ATT in these studies have varied from 6-24 months A meta-analysis of these studies revealed that 84 95 CI 79-89 of the patients receiving ATT had no recurrence of inflammation during the follow-up period
AIM of the study To compare the efficacy of 6-month with that of 9-month ATT for the treatment of clinically diagnosed tubercular posterior uveitis TPU
Study design An international multicenter prospective randomized observer masked-study in three centres spread across India Myanmar and Thailand
Patient assesment This included detailed history of ocular and systemic illnesses history of TB contact in past ETDRS best corrected visual acuity converted from Snellens if ETDRS unavailable intraocular pressure by Goldmann applanation tonometry slit lamp biomicroscopy and indirect ophthalmoscopy Fundus photography seven-field or wide-field if available was performed for all patients Other ocular imaging such as fluorescien angiography fundus autofluorescence optical coherence tomography OCT OCT-angiography or indocyanine green angiography were performed as per specific requirements in individual cases All patients with clinical signs compatible with TPU were investigated for complete blood counts erythrocyte sedimentation rate HIV VDRL TST and contrast enhanced computed tomography CECT of thorax If CECT is not available at a centre then a digital X-ray of the chest was considered in lieu of it IGRA was performed in conjunction with TST or in patients with strong suspicion of TPU but negative TST Additional investigations were performed at the discretion of the investigator to rule out non-TB diagnosis
Follow-up evaluation were done at 2 weeks 1 month -1 week 2 months -2 weeks 4 months -2 weeks 6 months -4 weeks 9 months -4weeks and then 3 monthly -4 weeks till one year after completion of ATT The one-year cut-off limit has been chosen since most recurrences have been known to occur within one year after the completion of ATT at least in case of pulmonary TB Ocular and systemic evaluation including ocular imaging as described above will be performed for each visit
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