Retinitis Pigmentosa with Cystoid Macular Edema
Conditions
Interventions
Treatment group:Treatment with Compound Pingdimu Granules
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Willingness to participate in the trial and provision of signed informed consent. (2) Meeting the diagnostic criteria for retinitis pigmentosa (RP). (3) Presence of at least one eligible study eye. (4) Documentation of RP-associated cystoid macular edema (CME) via optical coherence tomography (OCT) for at least three months with no treatment received for at least one month prior to enrollment. (5) Age between 18 and 80 years (inclusive) regardless of gender.
Exclusion criteria
Exclusion criteria: (1) Presence of severe systemic diseases (e.g. cardiovascular cerebrovascular hepatic or hematopoietic system diseases; life-threatening primary diseases; psychiatric or cognitive disorders) that may interfere with the study conduct or follow-up. (2) Presence of other ocular diseases such as optic nerve or retinal disorders glaucoma ocular autoimmune diseases or ocular surface diseases affecting visual function. (3) Suspected hepatic or renal dysfunction defined as serum creatinine levels exceeding the upper limit of normal or ALT/AST levels more than twice the normal range. (4) Current participation or participation within the past three months in other drug clinical trials or concurrent use of similar medications or therapies that may affect efficacy evaluation. (5) Known allergy to any component of the investigational drug. (6) Poor compliance making it difficult to complete the treatment. (7) Any other conditions deemed by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Macular Thickness (CMT);Changes in Best Corrected Visual Acuity (BCVA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Microperimetry Sensitivity; | — |
Countries
China
Contacts
Public ContactTaomin Huang/Jihong Wu
Eye & ENT Hospital of Fudan University
Outcome results
None listed