| CTRI Number |
CTRI/2024/07/071031 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Intravitreal injection for Diabetic Macular Edema |
|
Scientific Title of Study
|
Assessment of retinal sensitivity function in response to intravitreal injection therapy for diabetic macular edema (DME) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikitha Reddy |
| Designation |
Ophthalmologist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
L V Prasad Marg 1st Floor GPR Building Room No 123 Clinical Research Department
Road No 02 Banjara Hills Hyderabad 500034 Telangana India
Hyderabad TELANGANA 500034 India |
| Phone |
|
| Fax |
|
| Email |
nikitha@lvpei.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Padmaja Kumari Rani |
| Designation |
Ophthalmologist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
L V Prasad Marg 1st Floor GPR Building Room No 123 Clinical Research Department
Road No 02 Banjara Hills Hyderabad 500034 Telangana India
Hyderabad TELANGANA 500034 India |
| Phone |
9000151559 |
| Fax |
|
| Email |
rpk@lvpei.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Padmaja Kumari Rani |
| Designation |
Ophthalmologist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
L V Prasad Marg 1st Floor GPR Building Room No 123 Clinical Research Department
Road No 02 Banjara Hills Hyderabad 500034 Telangana India
Hyderabad TELANGANA 500034 India |
| Phone |
9000151559 |
| Fax |
|
| Email |
rpk@lvpei.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
L V Prasad Marg
Road No:02, Banjara Hills
Hyderabad 500034
Telangana
India |
| Type of Sponsor |
Other [Not for profit] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNikitha Gurram |
L V Prasad Eye Institute |
Room No 125, 1st floor, GPR building,Clinical Research Department,Road No:02, Hyderabad 500034,Telangana,India Hyderabad TELANGANA |
9912145673
nikitha@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravitreal Injection |
intravitreal injection therapy for diabetic macular edema.
Treatment naïve patients with DME who were advised intravitreal anti-VEGF injections.
Follow ups are baseline, 3 and 6 months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Treatment naïve patients diagnosed with DME receiving intravitreal antiVEGF injections
2.Diagnosis of DME was confirmed by a retinal specialist with contact lens biomicroscopy, and OCT findings indicating clinically significant macular edema increased central retinal thickness and the presence of fluid.
3.CRT is considered increased when it is greater than 250microns on SD-OCT
|
|
| ExclusionCriteria |
| Details |
1.Tractional component of DME
2.Previous intraocular surgery
3.Proliferative diabetic retinopathy with vitreous haemorrhage
4.Clinically significant cataract with media haze grade ≥ 3
5.Hearing, talking impaired adults
6.Pregnant women
7.Eyes which developed infection post treatment
Patients who developed any kind of infection/reaction post treatment will be excluded from the study and will be treated accordingly and will be reported to HICC committee /Data Safety Committee of LVPEI in order to prevent such scenarios in future.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) To evaluate the macular thickness, BCVA and vessel densities with OCT/OCTA in pre and post anti-VEGF injections in pro re nata (PRN) regimen
b) To compare macular threshold sensitivity in PRN radial sectors for diabetic macular edema
|
Baseline, 3 and 6 months follow-up visits. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| c) To correlate OCTA structural changes with macular threshold sensitivity from microperimetry. |
Baseline, 3 Months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="1" Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The prevalence of center-involving or referral diabetic macular edema (CI-DME) and non -center involving diabetic macular edema (NCI-DME) in the south urban population was 2.4 to 3.03% and 8.9 to 10.80% [1, 2] The overall prevalence for DME with tele-screening was 3.9% (95% CI: 3.7–4.1)[3]Monthly intravitreal injections of Bevacizumab for up to 6 months were administered for ischemic DME patients which improved best corrected visual acuity (BCVA) (20/180 to 20/74) and macular sensitivity (11.66 to 16.26 dB) without perfusion compromise in the macula. Capillary dropout areas in optical coherence tomography angiography (OCTA) correlated with lower retinal sensitivity in microperimetry. [4] Several types of anti-vascular endothelial growth factor’s (VEGF’s) are available for treatment in DME cases that include: bevacizumab, ranibizumab, aflibercept and conbercept. Among these aflibercept and conbercept have shown efficacy and safety in clinical trials. [5] Two years of a study conducted on DME showed no difference in visual outcomes, injection no and reduction of central macular thickness by bevacizumab, ranibizumab and aflibercept.[6] However, use of corticosteroid treatments such as triamcinolone, dexamethasone and fluocinolone acetonide can elevate intraocular pressure and cataract progression.[7] Thus the choice of therapy should be varied on case basis with the use of intravitreal anti-VEGFs on DME.[8] Anti-VEGFs also predicts the mean increase in logarithm of minimum angle of resolution (logMAR) in visual acuity during third and sixth months. There is also significant increase in macular sensitivity with decreased mean macular thickness.[9]OCTA evaluates DME with larger baseline foveal avascular zone areas (FAZ) in deep vascular plexus to have worsening visual acuity outcomes and higher decrease in superficial vascular plexus vessel density were associated with worsening of retinal sensitivity over one year.[10] These investigations can support OCTA the early detection and monitoring of diabetic macular ischemia rather than using fluorescein angiography (FA) which does not confirm the worsening of macular perfusion post-anti-VEGF treatment. [11] Also, OCTA studies have demonstrated the use of non-comparative case series during anti-VEGF treatment. This can create norms to identify diabetic macular ischemia (DMI) phenotypes during therapeutic interventions. These can be identified by using vascular and neuronal parameters to explain the recurrence of diabetic macular edema.[12] Mean retinal sensitivities within central 2° and 10° are lower in DME as compared to non-DME patients.[13] It will be interesting to see these sensitivity changes across different sectors with other alternative anti-VEGFs that can confirm the changes in macular ischemia. This study examines the evaluation of OCTA metrics for structure and
microperimetry for retinal sensitivity changes among pre and post-administration
of anti-VEGF injections in patients with diabetic macular edema.
|