Credevo: Expression of Interest Form for Participating in a Phase 4 Clinical Trial in Diabetic Retinopathy

Study Information

This is a Phase IV, randomized, double-blind, placebo-controlled clinical study evaluating an oral traditional/herbal investigational product in adult patients with treatment-naïve non-proliferative diabetic retinopathy (NPDR). The study duration is approximately 24 weeks, with oral dosing as per protocol and scheduled follow-up visits during the study period. The study plans to enrol adult patients with diabetes who have treatment-naïve, moderate to moderately severe non-proliferative diabetic retinopathy (NPDR), with or without diabetic macular edema (DME). If DME is present, it must be mild/stable, treatment-naïve, and not expected to require treatment during the study. No prior treatment for DR or DME, including: Anti-VEGF injections Laser therapy (focal, grid, PRP) Steroids Any retinal intervention. Please answer the following questions based on your site’s experience and interest in conducting a clinical study involving a traditional/herbal oral product.

1. Name *

First

Last

2. Phone

3. Work Email *

4. Degrees (comma separated, e.g., MBBS, MD, PhD, DNB) *

5. Please indicate your primary therapeutic area *

6. Profile Summary *

(Please provide a brief overview of your clinical and/or research experience, Including the total number of year of experience in clinical research )

7. Link to Site or Institution Page (Paste below).If no link is available, please write your site name. *

8. Upload Your CV (PDF)

Drag & Drop Files, Choose Files to Upload

9. Does your site currently manage adult patients (≥18 years) with moderate to moderately severe NPDR, with or without DME, who may be eligible for this study? *

Yes
No

Experience With Diabetic Retinopathy

This section seeks to understand your personal and site-level experience in diagnosing, managing, and treating patients with moderate to moderately severe NPDR (non-proliferative diabetic retinopathy ), with or without DME.

10. Approximately, how many patients are seen in your ophthalmology OPD per month at your site? *

11. Approximately how many diabetic retinopathy (DR) patients do you see per month at your site? *

12. Do you see patients with moderate to moderately severe NPDR in your OPD?(Patients with no prior laser, anti-VEGF, or steroid treatment) *

Yes
No

13. Approximately how many treatment-naïve patients with moderate or moderately severe NPDR (ETDRS DRSS 43 or 47) do you see per month? *

14. In your opinion, how many patients could potentially be screened for this study per month? *

15. In your opinion, how many patients do you expect to enroll in this study per month? *

16. Do you foresee any difficulties in recruiting treatment-naïve NPDR patients?

Yes
No

(If yes, please briefly describe the challenges you anticipate.)

coordinator's with steroid

(If yes, please briefly describe the challenges you anticipate.)

17. Do you have the following facilities available at your site? *

ETDRS visual acuity testing (4 m)
SD-OCT for CST measurement
Fundus photography

(Please tick all facilities that are available at your site)

18. Are you able to share retinal images with a central reading center? *

Yes
No

19. Would you be interested in participating as a Principal Investigator in this study? *

Yes
No
Maybe (subject to further discussion)

20. Please provide your study coordinator's name

First

Last

21. Please provide study coordinator's contact number

22. Please provide study coordinator's email address

Colleague Referral for Diabetic Retinopathy

We would appreciate your support in referring colleagues or investigators within your network who may have relevant experience in diabetic retinopathy.

23. Please provide the name of the investigator.

24. Please provide the email of the investigator.