RPE65

Chr 1ARAD

retinoid isomerohydrolase RPE65

Also known as: BCO3, LCA2, RP20, mRPE65, p63, rd12, sRPE65

The protein encoded by this gene is a component of the vitamin A visual cycle of the retina which supplies the 11-cis retinal chromophore of the photoreceptors opsin visual pigments. It is a member of the carotenoid cleavage oxygenase superfamily. All members of this superfamily are non-heme iron oxygenases with a seven-bladed propeller fold and oxidatively cleave carotenoid carbon:carbon double bonds. However, the protein encoded by this gene has acquired a divergent function that involves the concerted O-alkyl ester cleavage of its all-trans retinyl ester substrate and all-trans to 11-cis double bond isomerization of the retinyl moiety. As such, it performs the essential enzymatic isomerization step in the synthesis of 11-cis retinal. Mutations in this gene are associated with early-onset severe blinding disorders such as Leber congenital. [provided by RefSeq, Oct 2017]

GeneReviewsOMIMResearchGenerating clinical summary…

Primary Disease Associations & Inheritance

Leber congenital amaurosis 2MIM #204100
AR
Retinitis pigmentosa 20MIM #613794
AR
Retinitis pigmentosa 87 with choroidal involvementMIM #618697
AD

Clinical highlights

Gene-disease validity (ClinGen)
RPE65-related recessive retinopathy · ARDefinitivesufficient evidence for diagnostic panels2 gene-disease associations curated in total
Interpreting a novel variant
Loss of function is the curated mechanism (Gene2Phenotype), though the gene is not strongly LoF-constrained in the population — weigh truncating variants against that tolerance.Curated gene-level mechanism — a prior for triage, not a per-variant call.
10
Active trials
130
Pubs (1 yr)
P/LP submissions
P/LP missense
1.11
LOEUF
LOF
Mechanism· G2P
📖
GeneReview available — RPE65
Authoritative clinical overview · Recommended first read
Open GeneReview ↗

Population Genetics & Constraint

gnomAD v4 — loss-of-function & missense intolerance

Tolerant — LoF & missense variants common in population
LoF Constraint?
1.11LOEUF
pLI 0.000
Z-score 1.07
OE 0.79 (0.571.11)
Tolerant

Highly tolerant — LoF variants common in population

Missense Constraint?
-0.24Z-score
OE missense 1.04 (0.941.15)
284 obs / 272.8 exp
Tolerant

Tolerant to missense variation

Observed / Expected Ratios?
LoF OE?0.79 (0.571.11)
00.351.4
Missense OE?1.04 (0.941.15)
00.61.4
Synonymous OE?1.20
01.21.6
LoF obs/exp: 24 / 30.4Missense obs/exp: 284 / 272.8Syn Z: -1.54

ClinVar Variant Classifications

0 submitted variants in ClinVar

Protein Context — Lollipop Plot

RPE65 · protein map & ClinVar variants

Showing all ClinVar variants across the protein. Search a specific variant to highlight its position.

Clinical Trials

Active and recruiting trials from ClinicalTrials.gov

Biallelic RPE65 Mutation-associated Retinal Dystrophy

Gene Therapy in Subjects With Biallelic RPE65 Mutation-associated Retinal Dystrophy

RECRUITING
NCT05858983Phase PHASE1, PHASE2Frontera TherapeuticsStarted 2022-11-30
FT-001 Low DoseFT-001 Mid DoseFT-001 High Dose
Leber Congenital Amaurosis

Phase 1 Follow-on Study of AAV2-hRPE65v2 Vector in Subjects With Leber Congenital Amaurosis (LCA) 2

ACTIVE NOT RECRUITING
NCT01208389Phase PHASE1, PHASE2Spark Therapeutics, Inc.Started 2010-11
voretigene neparvovec-rzyl
To Evaluate the Scaling Clinical Study of AAV2-RPE65 Gene Therapy Agent (LX101) in Patients With Congenital Amaurosis (LCA)

An Expanded Clinical Study Evaluating the AAV2-RPE65 Gene Therapy(LX101) in Patients With LCA

NOT YET RECRUITING
NCT06024057Phase NAShanghai General Hospital, Shanghai Jiao Tong University School of MedicineStarted 2023-09-01
LX101
Inherited Retinal Dystrophy Associated With RPE65 Mutations

Safety and Tolerability of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations

ACTIVE NOT RECRUITING
NCT06196827Phase PHASE1Innostellar Biotherapeutics Co.,LtdStarted 2022-07-02
LX101
Inherited Retinal Dystrophy Associated With RPE65 Mutations

Efficacy and Safety of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations

ACTIVE NOT RECRUITING
NCT07054632Phase PHASE3Innostellar Biotherapeutics Co.,LtdStarted 2023-09-13
LX101
Retinal DegenerationsRetinitis Pigmentosa (RP)Stargardt Disease

Inherited Retinal Diseases: Natural History and Genotype-Phenotype Correlations

NOT YET RECRUITING
NCT07265895IRCCS San RaffaeleStarted 2026-01-01
No Intervention: Observational Cohort
Leber Congenital Amaurosis

Leber Congenital Amaurosis Inherited Blindness of Gene Therapy Trial(LIGHT)

ACTIVE NOT RECRUITING
NCT06088992Phase EARLY_PHASE1Xinhua Hospital, Shanghai Jiao Tong University School of MedicineStarted 2023-01-10
HG004
Inherited Retinal Dystrophy Due to RPE65 Mutations

Long-term Follow-up Study in Subjects Who Received Voretigene Neparvovec-rzyl (AAV2-hRPE65v2)

ACTIVE NOT RECRUITING
NCT03602820Genentech, Inc.Started 2015-06
AAV2-hRPE65v2
Leber Congenital AmaurosisInherited Retinal Diseases Caused by RPE65 Mutations

Safety and Efficacy Trial of HG004 for Leber Congenital Amaurosis Related to Rpe65 Gene Mutations (STAR)

RECRUITING
NCT05906953Phase PHASE1, PHASE2HuidaGene Therapeutics Co., Ltd.Started 2023-10-31
HG004
Inherited Retinal Dystrophy Due to RPE65 MutationsLeber Congenital Amaurosis

Safety and Efficacy Study in Subjects With Leber Congenital Amaurosis

ACTIVE NOT RECRUITING
NCT00999609Phase PHASE3Spark Therapeutics, Inc.Started 2012-10
AAV2-hRPE65v2,voretigene neparvovec-rzyl