Ophthalmology2002CohortRetinal/Sensoryā˜… Moderate Quality

Epitalon in the Treatment of Retinitis Pigmentosa

PMID: 12195242

Khavinson V.K., Grigorian E.N.

St. Petersburg Institute of Bioregulation and Gerontology

Neuroendocrinology Letters 23(4): 365-368

Study Type
Cohort
Sample Size
n = 40
Tx: 40
Duration
12 months
Citations
127(23 yrs)

Abstract

Retinitis Pigmentosa (RP) is a group of inherited retinal degenerations leading to progressive blindness, with no established cure. This open-label cohort study evaluated the neuroprotective effects of Epitalon in RP patients. Forty patients (age 28-67 years) with various RP subtypes received intramuscular Epitalon (1mg daily for 10 days) every 4 months for 12 months. Visual field perimetry showed significant expansion of functional retinal area in 36/40 patients (+7.0Ā±2.3 degreesĀ², p<0.05). Electroretinography revealed increased b-wave amplitude (58.5Ā±21.3 Ī¼V at 12 months vs. baseline 47.3Ā±18.2 Ī¼V, p<0.01), indicating improved bipolar cell function. Visual acuity was maintained or improved in 73% of cases. No serious adverse events occurred. The positive response rate (90%) suggests Epitalon may work by stimulating retinal progenitor cells or preventing photoreceptor apoptosis.

Study Population

Patients with Retinitis Pigmentosa (age 28-67 years), various genetic subtypes, moderate to advanced disease

Context

Retinitis Pigmentosa is a genetic condition causing progressive blindness. Epitalon was tested for its neuroprotective effects on the retina.

Findings

In 90% of the treated patients, Epitalon exerted a positive effect. Visual field loss was halted or reversed, and electroretinography (ERG) showed improved function of the retinal neurons.

Significance

Epitalon is a promising therapeutic agent for retinal degenerations, likely due to its ability to stimulate retinal cell metabolism and regeneration.

Statistical Results

Visual field area: baseline 38.2Ā±12.4 degreesĀ² vs. 12 months 45.2Ā±14.1 degreesĀ² (p<0.05). ERG b-wave amplitude: baseline 47.3Ā±18.2 Ī¼V vs. 12 months 58.5Ā±21.3 Ī¼V (p<0.01). Visual acuity (Snellen): 73% maintained or improved. Positive response rate: 90%.

Study Limitations

  • ā€¢No randomized control group
  • ā€¢Heterogeneous patient population (different RP genetic subtypes)
  • ā€¢Subjective endpoint (visual field testing)
  • ā€¢Limited mechanistic investigation
  • ā€¢Russian patient population - limited international validation

Key Findings

  • āœ“Positive effect in 90% of patients
  • āœ“Improved retinal electrical activity
  • āœ“Preservation of vision

Mechanism of Action

Stimulation of retinal cell proliferation and differentiation.

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