Fluocinolone Acetonide Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple clinical trials evaluate fluocinolone acetonide for ophthalmological applications, specifically targeting uveitis and diabetic macular edema. The trial landscape features a recruiting study sponsored by The Cleveland Clinic focused on imaging intravitreal implants in uveitis, alongside a completed Phase 3 trial sponsored by Alimera Sciences examining intravitreal inserts for diabetic macular edema. Overall, clinical evaluation encompasses Phase 3 and unassigned trial phases conducted by academic medical centers and corporate sponsors across recruiting and completed recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04340505	Recruiting	Uveitis	The Cleveland Clinic	2019-08-08	--
NCT00490815	Completed	Diabetic Macular Edema	Alimera Sciences	2007-08	Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Fluocinolone Acetonide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluocinolone acetonide selectively binds to cytosolic glucocorticoid receptors, translocating to the nucleus to induce lipocortin expression and inhibit phospholipase A2, which blocks the release of arachidonic acid and subsequent biosynthesis of pro-inflammatory prostaglandins and leukotrienes. This biochemical inhibition reduces microvascular permeability and cellular inflammatory infiltration, ultimately mitigating tissue edema and inflammation in clinical conditions such as uveitis and diabetic macular edema.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).