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CTRI Number  CTRI/2022/01/039632 [Registered on: 21/01/2022] Trial Registered Prospectively
Last Modified On: 18/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Dexamethasone implant in the treatment of central serous chorioretinopathy 
Scientific Title of Study   Efficacy of intravitreal dexamethasone injection in chronic, atypical, and recurrent central serous chorioretinopathy. A prospective pilot study. 
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 Umesh Chandra Behera 
Designation  Consultant, Retina and Vitreous Services 
Affiliation  L V Prasad Eye Institute 
Address  Academic Block, Ground Floor Mithu Tulsi Chanrai Campus, Patia
Bhubaneswar
Khordha
ORISSA
751024
India 
Phone  9853011697  
Fax  06742653130   
Email  umesh@lvpei.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Umesh Chandra Behera 
Designation  Consultant, Retina and Vitreous Services 
Affiliation  L V Prasad Eye Institute 
Address  Academic Block, Ground Floor, Mithu Tulsi Chanrai Campus, Patia
Bhubaneswar
Khordha
ORISSA
751024
India 
Phone  9853011697  
Fax  06742653130   
Email  umesh@lvpei.org  
 
Details of Contact Person
Public Query  
Name  Mohammed Hasibur Rahman  
Designation  Clinical Research Supervisor 
Affiliation  L V Prasad Eye Institute 
Address  Academic Block, Ground Floor Clinical Research Department, Mithu Tulsi Chanrai Campus, Patia
Bhubaneswar
Khordha
ORISSA
751024
India 
Phone  06742653261  
Fax  06742653130   
Email  alhasib49@gmail.com  
 
Source of Monetary or Material Support  
Hyderabad Eye Research Foundation 
 
Primary Sponsor  
Name  Hyderabad Eye Research Foundation  
Address  L V Prasad Eye Institute MTC Campus, Patia, Bhubaneswar  
Type of Sponsor  Research institution 
 
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 
Dr Umesh Chandra Behera  L V PRASAD EYE INSTITUTE  Academic Block, Ground Floor Clinical Research Department Mithu Tulsi Chanrai Campus Patia Bhubaneswar
Khordha
ORISSA 		 9853011697
06743987130
umesh@lvpei.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional 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: H357||Separation of retinal layers,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravitreal Ozurdex Implantation  Intravitreal Ozurdex Implantation Single Dose Follow up- Weekly for 2 weeks, 6 weeks, 12 weeks, 3 monthly thereafter till 1 year 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  46.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients with non-resolving and recurrent CSCR with focal, multifocal, or diffuse leaks on FA
2. Eyes with focal leaks within 1000microns of the center of fovea in chronic CSCR
3. Best corrected vision score of 73 to 34 at test distance of 4 meters on ETDRS chart at recruitment (Snellen equivalent 20/40 to 20/200)
4. Decrease in vision primarily secondary to CSCR
5. Willing to sign informed consent form 
 
ExclusionCriteria 
Details  1. Laser or pharmacological treatment for CSCR in previous six months
2. Eyes with choroidal neovascularization demonstrated on OCTA/FA/ICGA
3. Fellow eye vision worse than 20/200
4. Aphakia
5. Patients with glaucoma. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Complete resolution of SRF as determined on OCT
The disappearance of intraretinal cystoid spaces
Visual acuity change
Change in contrast sensitivity
Change in mfERG waveforms
Change in intraocular pressure
 		 6 and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Reappearance of disease
% Requiring retreatment
Changes in PED height
Lens changes
% Requiring medical/surgical treatment for glaucoma
 		 3,6,9 and 12 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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   N/A 
Date of First Enrollment (India)   31/01/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Background: Central serous chorioretinopathy (CSC), characterized by an idiopathic serous neurosensory retinal detachment, has unclear pathogenesis. Choroidal hyperpermeability and retinal pigment epithelial (RPE) dysfunction have been suggested as possible mechanisms. While the benign nature of acute CSC is known, treatment challenges remain for chronic, atypical, and recurrent central serous chorioretinopathy because persistent fluid at macula results in permanent RPE damage and consequent vision loss. Treatment aims to preserve the outer neurosensory retinal layers and achieve complete resolution of the subretinal fluid (SRF) and intraretinal fluid (IRF), as even a tiny amount of remaining SRF can lead to irreversible damage to photoreceptors.  

Both thermal and photochemical lasers like photodynamic therapy (PDT) have been advocated for treating these eyes. Chronic CSC (cCSC) with broad and indistinct leakage where thermal lasers are believed to be more damaging, PDT proves to be safer and efficacious in reducing SRF and improving visual acuity. But the non-availability of Verteporfin has forced retina surgeons to damaging thermal lasers in recent times. While both the interventions may result in RPE atrophy, PDT, in addition, may cause choroidal hypoperfusion and neovascular complications. Subthreshold lasers have also been tried in cCSC, but the need for confluent treatment spots in the absence of visible burns is a challenge. 

Rationale: Dexamethasone has the highest relative clinical efficacy of any corticosteroid applied to ophthalmology practice and exerts its’ multiple effects via its’ influence on numerous signal transduction pathways. It has been approved for treating macular edema in retinal venous occlusions and non-infectious uveitis. Studies of diabetic macular edema treatment have demonstrated that dexamethasone implant may be an alternative treatment in recalcitrant edema owing to its’ anti-inflammatory, anti-permeability, and angiostatic effects. In age-related macular degeneration, anti-VEFG resistant choroidal neovascular complications responded well to a combination treatment of dexamethasone and anti-VEGF by improving retinal fluid resorption. CSC, a disease in which patients are advised to avoid corticosteroids in all forms anecdotal reports of Intravitreal triamcinolone injection have reported equivocal results. Intravitreal triamcinolone in chronic CSC, in a single case report, Jonas et al. did not find marked benefit, but Patron et al. showed complete resolution of cystoid changes secondary to cCSC.As dexamethasone implant as a rescue treatment in cCSC has never been tried in a prospective clinical study, we intend to determine its’ efficacy in chronic, atypical and recurrent central serous chorioretinopathy.


 
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