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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  
L V Prasad Eye Institute 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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