Trials Sponsors Conditions Drugs Pricing

Conditions

Neovascular (Wet) Age-related Macular Degeneration (nAMD)

Outcome Measures

Primary Outcomes (1)

Evaluation of safety and tolerability
Frequency, type, and intensity of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs)
Throughout 52 weeks

Secondary Outcomes (3)

Evaluation of potential efficacy
52 weeks post administration
Evaluation of potential safety
Through week 24
Evaluation of supplementary therapy injections received
Throughout 52 weeks post administration

Study Arms (1)

EXG102-031

EXPERIMENTAL

Each participant will receive a single subretinal injection of EXG102-031 in the study eye. Participants will be enrolled into one of four dosage groups sequentially, and the dose administered will be determined based on which study group the participant is enrolled into.

Biological: EXG102-031

Interventions

EXG102-031Biological

EXG102-031 is a recombinant adeno-associated virus (rAAV) expressing an angiopoietin domain and VEGF receptor (ABD-VEGFR) fusion protein. EXG102-031 will be administered by subretinal injecting into one eye of each participant.

EXG102-031

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, age ≥ 50 years of age;
Diagnosis of nAMD and current active lesion in the study eye at Screening;

Sponsors & Collaborators

Exegenesis Bio
Industrylead

Study Sites (2)

Sierra Eye Associates

Reno, Nevada, 89502, United States

Erie Retina Research

Erie, Pennsylvania, 16507, United States

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

Arshad Khanani, MD
Sierra Eye Associates
PRINCIPAL INVESTIGATOR

Enrollment

12 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

July 24, 2023

Actual (reported)

A Study of EXG102-031 in Patients With wAMD (Everest)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

EXG102-031

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

EXG102-031

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations