| CTRI Number |
CTRI/2024/07/070519 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of eyesight related outcome and quality of life during course of treatment with ANTI-VEGF injection in diabetic patients. |
|
Scientific Title of Study
|
Assessment of visual outcome and quality of life during the course of treatment with intravitreal anti-VEGF injection in patients with diabetic macular edema. |
| 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 Neha Sethi |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College and hospital Faridkot |
| Address |
Kotkapura, Faridkot , Punjab ( Pin code-151204)
Faridkot
PUNJAB
161204
India |
| Phone |
9888129095 |
| Fax |
|
| Email |
neha.knew@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N R Gupta |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh medical college and hospital Faridkot |
| Address |
Room number-72 OPD Block Department of ophthalmology GGS Medical college, Faridkot , Punjab (pin code-151203)
Faridkot
PUNJAB
151203
India |
| Phone |
9872652220 |
| Fax |
|
| Email |
nrgupta6@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Sethi |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College and hospital Faridkot |
| Address |
Room number 72 OPD Block , Department of ophthalmology , Guru Gobind Singh Medical College and Hospital , Faridkot , Punjab (151203)
PUNJAB
161204
India |
| Phone |
9888129095 |
| Fax |
|
| Email |
neha.knew@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD Block Department of ophthalmology , Guru Gobind Singh Medical College and hospital Faridkot (pin code-151203) |
|
|
Primary Sponsor
|
| Name |
Ramanpreet Kaur |
| Address |
Street number-2 Moti Bagh Colony Nabha district Patiala Punjab(pin code-147201) |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Ramanpreet Kaur |
Guru Gobind Singh medical college and hospital Faridkot |
Junior Resident room ,Department of ophthalmology ward block
Faridkot
PUNJAB |
9878000852
raman.preet0852@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GGS Medical college and hospital ,Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H30-H36||Disorders of choroid and retina, (2) ICD-10 Condition: H358||Other specified retinal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with center involving diabetic macular edema requiring anti-VEGF injections
Patients who are already undergoing treatment with intravitreal anti-VEGF injections |
|
| ExclusionCriteria |
| Details |
Patients with media opacities due to dense cataract , vitreous hemorrhage etc in whom it is difficult to assess posterior segment
Patients with recent stroke less than 3 months who cannot be injected anti-VEGF
Patient with other chronic comorbidities example inability to walk , hearing loss or visual loss due to causes other than DME that may affect quality of life
Patients undergoing other intravitreal injections like steroids
Patients who are not able to have adequate hearing and sight cognition to be able to complete interview questions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Visual acuity (log Mar scale) in patients before undergoing intravitreal anti VEGF injections in diabetic macular edema
2. The quality of life (NEI VFQ25 )in patients undergoing intravitreal anti-VEGF injections in diabetic macular edema
3. Visual acuity (log Mar scale)in patients with diabetic macular edema after intra vitreal anti-VEGF injections at 4 weeks,8 weeks,12 weeks. |
Visual acuity and NEIVFQ-25 score - baseline, 4 weeks, 8 weeks, 12 weeks after anti-VEGF injection.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual acuity (log Mar scale)in patients with diabetic macular edema after intra vitreal anti-VEGF injections at 4 weeks,8 weeks,12 weeks. |
Visual acuity (log Mar scale)in patients with diabetic macular edema after intra vitreal anti-VEGF injections at 4 weeks, 8 weeks,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response (Others) - Researchers can assess the data after requesting through email / etc.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [raman.preet0852@gmail.com].
- For how long will this data be available start date provided 07-07-2024 and end date provided 02-07-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aims and objectives To assess visual acuity in patients before undergoing intravitreal anti-VEGF injections in diabetic macular edema To assess the quality of life in patients undergoing intravitreal anti-VEGF injections in diabetic macular edema To assess visual acuity in patients with diabetic macular edema after intravitreal anti -VEGF injections To assess quality of life after the course of treatment with intravitreal anti-VEGF injections in diabetic macular edema Inclusion criteria Patients with center involving diabetic macular edema requiring anti-VEGF injections Patients who are already undergoing treatment with intravitreal anti-VEGF injections Exclusion criteria Patients with media opacities due to dense cataract , vitreous hemorrhage etc in whom it is difficult to assess posterior segment Patients with recent stroke less than 3 months who cannot be injected anti-VEGF Patient with other chronic comorbidities example inability to walk , hearing loss or visual loss due to causes other than DME that may affect quality of life Patients undergoing other intravitreal injections like steroids Patients who are not able to have adequate hearing and sight cognition to be able to complete interview questions Material and methods The study will be conducted at department of ophthalmology at guru Gobind Singh medical college and hospital, Faridkot, Punjab. After applying inclusion and exclusion criteria, patients selected for study will undergo detailed ophthalmological examination and will be asked visual function questionnaire 25 and score will be calculated Then after intravitreal anti-VEGF injection patient will be followed up at monthly intervals and again detailed ophthalmological examination will be done including questionnaire regarding patient expectations during intravitreal anti-VEGF injection. Therefore , this study’s aim is to assess visual outcome and quality of life during intravitreal injections in patients with diabetic macular edema.
|