| 1 |
Dr. Anindita Mandal |
aninditamondal65@yahoo.com |
ICR/21/021 |
|
Ethics Committee Submission: Study for Review & Approval |
| 2 |
Dr. Ashis Majumdar |
ashismajumdar5792@gmail.com |
Enhanced Dermoid Excision with ALK |
DermoidALK-01 |
Ethics Committee Submission: Studies for Review & Approval |
| 3 |
Dr. Ashis Majumdar |
ashismajumdar5792@gmail.com |
Keratoconus Severity and Hormonal Dysregulation |
KSHD-01 |
Ethics Committee Submission: Study for Review & Approval |
| 4 |
Dr. Ashis Majumdar |
ashismajumdar5792@gmail.com |
BB DALK vs. DOB DALK |
BBDOBDALK-01 |
Ethics Committee Submission: Study for Review & Approval |
| 5 |
Dr. Ashis Majumdar |
ashismajumdar5792@gmail.com |
PVI-Dexa Vs. Moxi-Dexa in EKC |
PVDexEKC-01 |
Ethics Committee Submission: Study for Review & Approval |
| 6 |
Dr. Lakshmi Kanta Mondal |
lakshmi.mondal62@gmail.com |
A prospective, multi-center, single arm, open label, study to evaluate safety and efficacy of RanizuRelTM containing Ranibizumab for intra-vitreal injection , manufactured by Reliance Life Sciences, Pvt. Ltd. India in patients with neovascular (wet) age-related macular degeneration |
RLS/OPT/2020/03 |
Ethics Committee Submission: Study for Review & Approval |
| 7 |
Dr. Soumyadeep Majumdar |
soumyanbmc@gmail.com |
A Prospective, Interventional, Single Arm, Multi-Centre, Phase 4 Study to Assess the Safety and Efficacy of Ranibizumab in Participants with Retinopathy of Prematurity. |
0248-22 |
Ethics Committee Submission: Study for Review & Approval |
| 8 |
Dr. Asim Kumar Ghosh |
drasimkumarg@gmail.com |
A PHASE IIIB, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO INVESTIGATE FARICIMAB (RO6867461) TREATMENT RESPONSE IN TREATMENT-NAÏVE, UNDERREPRESENTED ASIAN INDIAN PATIENTS WITH DIABETIC MACULAR EDEMA |
ML43435 |
Ethics Committee Submission: Amendment of Study for Review & Approval |
| 9 |
Dr. Asim Gosh |
yasmeen@eclinicalresearch.in |
A PHASE IIIB, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO INVESTIGATE FARICIMAB (RO6867461) TREATMENT RESPONSE IN TREATMENT-NAÏVE, UNDERREPRESENTED ASIAN INDIAN PATIENTS WITH DIABETIC MACULAR EDEMA. |
ML43435 |
The main changes (summarized below) in this update of the Investigator’s Brochure
are as follows:
1- IB v 12
2-In addition to the vial configuration, the faricimab drug product is provided as a
singledose 0.5 mL PFS containing the identical drug product composition
(6 mg/0.05 mL) as the vial product configuration with an L-histidine/acetate
buffered solution (approximately pH 5.5) containing sodium chloride, sucrose, L-
methionine, polysorbate 20, and water for injection. The PFS forms an integral
drug device combination product with the extended finger flange and the
coupled plunger rod and is currently under investigation. A single use 30G 0.5”
extra thin wall injection filter needle is copacked and should be used for
administration. |
| 10 |
Dr. Lakshmi Kanta Mondal |
lakshmi.mondal62@gmail.com |
Genetic Analysis of Ophthalmologic Disorders (Version No. 1.1, dated 29 Aug, 2023) |
SLS-OPD-01 |
For EC Submission |
| 11 |
Dr. Tania Ray Bhadra |
drtaniaray@gmail.com |
: A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, bioequivalence study with clinical endpoint comparing gencric bimatoprost ophthalmic solution 0.01% and LUMIGANa (bimatoprost ophthalmic solution) 0.01% in the treatment of subjects with chronic open-angie glaucoma or ocular hypertension in both eyes. |
MW230021 |
For EC Submission |
| 12 |
Dr. Asim Kumar Ghosh |
drasimkumarg@gmail.com |
A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD) |
OPT-302-1004 |
Amendment |
| 13 |
Dr. Asim Kumar Ghosh |
soumyanbmc@gmail.com |
A PHASE IV, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION OR DIABETIC MACULAR EDEMA TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE FARICIMAB INTRAVITREAL INJECTION IN INDIA (VITREAL STUDY) |
ML45007 |
TEST COMPOUND(S):
Faricimab 120 mg/mL solution for injection (single dose of 6 mg/0.05mL).
STUDY RATIONALE:
The purpose of this study is to assess the safety and efficacy of faricimab, a novel bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A, to address a significant unmet medical need in patients with NeoVascular Age-Related Macular Degeneration or Diabetic Macular Edema. |
| 14 |
ASIM KUMAR GHOSH |
yasmeen@eclinicalresearch.in |
A PHASE IIIB, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO INVESTIGATE FARICIMAB (RO6867461) TREATMENT RESPONSE IN TREATMENT-NAÏVE, UNDERREPRESENTED ASIAN INDIAN PATIENTS WITH DIABETIC MACULAR EDEMA” |
ML43435 |
ICF Addendum v1 (India Only),IB v13, IB v13 Addendum 1 |
| 15 |
Dr. Asim Kumar Ghosh |
soumyanbmc@gmail.com |
A Phase IV, Multicentre, Open-Label, Single-Arm Study in Patients with NeoVascular Age Related Macular Degeneration or DIabetic Macular Edema to Evaluate the SafeTy and Effectiveness of the Faricimab intravitREAL injection (VITREAL Study) |
ML45007 |
Ethics Committee Submission: Study for Review & Approval |
| 16 |
Dr. Lakshmi Kanta Mondal |
lakshmi.mondal62@gmail.com |
A multicenter, open label, randomized, active controlled, comparative, parallel group, phase 3 non-inferiority, clinical study to evaluate efficacy and safety of CPL0702 ophthalmic solution versus dorzolamide 2% ophthalmic solution and Brimonidine 0.1% ophthalmic solution given concurrently in subjects with primary open angle glaucoma (POAG) or ocular hypertension (OHT). |
CP/03/23 |
Ethics Committee Submission: Studies for Review & Approval |
| 17 |
Dr. Asim Kumar Ghosh |
drasimkumarg@gmail.com |
A prospective, multi-center, open-label, phase IV study to evaluate the safety and effectiveness of intravitreal injections (IVI) of Brolucizumab in patients with Diabetic Macular Edema (DME). |
CRTH258BIN01 |
Ethics Committee Submission: Study for Review & Approval |
| 18 |
Dr. Lakshmi Kanta Mondal |
lakshmi.mondal62@gmail.com |
A prospective, multi-centre, randomized, double blind, parallel, active controlled, phase III study to compare the efficacy, safety, and immunogenicity of Aflibercept of Shilpa Biologicals Private Limited (SBPL) with EYLEA® (Aflibercept) of Bayer AG in subjects with Neovascular Age-related Macular Degeneration (Wet AMD) |
CBCC/2022/011 |
EC Submission |
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