55 and older, any sex, with Dry Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Change From Baseline to Week 72 in Geographic Atrophy (GA)Primary· Baseline, Weeks 12, 24, 36, 48 and 72
GA area as measured by fundus autofluorescence (FAF)
Week 12 (n=75,71,72)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
0.730
± 0.0625
GT005 High Dose [2E11 vg]
0.752
± 0.0634
Untreated Control
0.667
± 0.0647
Week 24 (n=72,75,71)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
1.151
± 0.0833
GT005 High Dose [2E11 vg]
1.260
± 0.0831
Untreated Control
1.054
± 0.0860
Week 36 (n=66,66,71)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
1.728
± 0.1488
GT005 High Dose [2E11 vg]
1.955
± 0.1503
Untreated Control
1.531
± 0.1528
Week 48 (n=64,68,65)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
2.098
± 0.1841
GT005 High Dose [2E11 vg]
2.535
± 0.1853
Untreated Control
2.047
± 0.1896
Week 72 (n=56,51,54)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
3.225
± 0.2337
GT005 High Dose [2E11 vg]
3.421
± 0.2369
Untreated Control
2.919
± 0.2412
The Change From Baseline at Week 96 in Geographic Atrophy (GA)Secondary· Baseline, Week 96
GA area as measured by fundus autofluorescence (FAF)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
4.414
± 0.3109
GT005 High Dose [2E11 vg]
4.607
± 0.3167
Untreated Control
3.769
± 0.3286
Summary of Adverse EventsSecondary· Adverse events are reported from randomization to the end of study, at Week 96, up to a maximum timeframe of approximately 96 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject.
A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.
Subjects with at least one ocular adverse event for the study eye
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
66
GT005 High Dose [2E11 vg]
65
Untreated Control
15
Subjects with at least one ocular adverse event for the fellow eye
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
32
GT005 High Dose [2E11 vg]
35
Untreated Control
14
Subjects with at least one non-ocular adverse event
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
63
GT005 High Dose [2E11 vg]
59
Untreated Control
44
Subjects with at least one ocular adverse event related to study treatment for the study eye
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
13
GT005 High Dose [2E11 vg]
21
Untreated Control
0
Subjects with at least one non-ocular adverse event related to study treatment
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
0
GT005 High Dose [2E11 vg]
0
Untreated Control
0
Subjects with at least one ocular adverse event related to surgical procedure for the study eye
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
48
GT005 High Dose [2E11 vg]
48
Untreated Control
0
Subjects with at least one non-ocular adverse event related to surgical procedure
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
0
GT005 High Dose [2E11 vg]
0
Untreated Control
0
Subjects with at least one ocular adverse event related to study procedure for the study eye
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
8
GT005 High Dose [2E11 vg]
9
Untreated Control
0
Ocular AEs Occurring in ≥2% of Subjects by Primary System Organ Class and Preferred Term for the Study EyeSecondary· Adverse events are reported from randomization to the end of study, at Week 96, up to a maximum timeframe of approximately 96 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject.
A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.
System organ classes are sorted alphabetically, and preferred terms are sorted by decreasing overall frequency within system organ class.
Subjects with at least one event
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
66
GT005 High Dose [2E11 vg]
65
Untreated Control
15
Eye disorders
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
65
GT005 High Dose [2E11 vg]
62
Untreated Control
14
-Cataract
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
21
GT005 High Dose [2E11 vg]
20
Untreated Control
3
-Retinal pigmentation
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
12
GT005 High Dose [2E11 vg]
22
Untreated Control
0
-Conjunctival haemorrhage
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
18
GT005 High Dose [2E11 vg]
12
Untreated Control
1
-Retinal haemorrhage
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
8
GT005 High Dose [2E11 vg]
10
Untreated Control
2
-Eye pain
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
5
GT005 High Dose [2E11 vg]
7
Untreated Control
0
-Ocular hypertension
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
6
GT005 High Dose [2E11 vg]
6
Untreated Control
0
Non-ocular AEs Occurring in ≥2% of SubjectsSecondary· Adverse events are reported from randomization to the end of study, at Week 96, up to a maximum timeframe of approximately 96 weeks.
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a subject or clinical investigation subject.
A TEAE is defined as any AE that develops after randomization or any AE already present that worsens following randomization. The primary summaries of AEs are based on TEAEs.
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
63
GT005 High Dose [2E11 vg]
59
Untreated Control
44
Change in GA Morphology From Baseline to Week 96 on Multimodal Imaging - Number of Participants With Increase in Fundus AutofluorescenceSecondary· Baseline, Weeks 5, 12, 24, 36, 48, 72 and 96
Change in retinal morphology on multimodal imaging.
For the untreated control group, there were no protocol-specified visits at Week 5.
Week 5 (n=23,24,0)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
23
GT005 High Dose [2E11 vg]
23
Week 12 (n=75,73,74)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
74
GT005 High Dose [2E11 vg]
73
Untreated Control
73
Week 24 (n=75,78,72)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
72
GT005 High Dose [2E11 vg]
78
Untreated Control
71
Week 36 (n=70,70, 71)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
66
GT005 High Dose [2E11 vg]
69
Untreated Control
70
Week 48 (n=67,72,68)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
67
GT005 High Dose [2E11 vg]
71
Untreated Control
68
Week 72 (n=61, 62,59)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
60
GT005 High Dose [2E11 vg]
60
Untreated Control
56
Week 96 (n=52,49, 34)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
50
GT005 High Dose [2E11 vg]
48
Untreated Control
33
Change in Best Corrected Visual Acuity (BCVA) Score From Baseline Through Week 96 Via the Early Treatment for Diabetic Retinopathy (ETDRS) ChartSecondary· Baseline, Weeks 1, 5, 8, 12, 24, 36, 48, 72 and 96
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
Min and max possible scores are 0-100 respectively. A higher score represents better visual functioning.
For the untreated control group, there were no protocol-specified visits for Weeks 1, 5 and 8.
Week 1 (n=81,78,0)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-2.0
± 1.54
GT005 High Dose [2E11 vg]
-7.0
± 1.56
Week 5 (n=81,78,0)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-0.8
± 0.88
GT005 High Dose [2E11 vg]
-3.3
± 0.89
Week 8 (n=79,77,0)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-0.1
± 0.85
GT005 High Dose [2E11 vg]
-1.7
± 0.86
Week 12 (n=79,79,73)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-1.1
± 0.91
GT005 High Dose [2E11 vg]
-2.5
± 0.91
Untreated Control
-0.7
± 0.96
Week 24 (n=78,78,71)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-2.7
± 1.03
GT005 High Dose [2E11 vg]
-6.3
± 1.03
Untreated Control
-1.1
± 1.09
Week 36 (75,74,72)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-2.5
± 1.24
GT005 High Dose [2E11 vg]
-7.7
± 1.25
Untreated Control
-3.0
± 1.30
Week 48 (n=73,75,69)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-2.6
± 1.48
GT005 High Dose [2E11 vg]
-7.3
± 1.46
Untreated Control
-5.3
± 1.54
Week 72 (n=63, 70, 58)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-4.1
± 1.54
GT005 High Dose [2E11 vg]
-7.9
± 1.50
Untreated Control
-8.8
± 1.61
Change in Low Luminance Difference (LLD) Letter Count From Baseline at Weeks 12, 24, 36, 48, 72 and 96, Via Early Treatment for Diabetic Retinopathy (ETDRS) ChartSecondary· Baseline, Weeks 12, 24, 36, 48, 72 and 96
LLD was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.
The test was to be performed after BCVA testing, prior to pupil dilation, and distance refraction was to be carried out before Low Luminance Visual Acuity (LLVA) was measured.
LLVA was to be measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the subject read the normally illuminated ETDRS chart. The LLD was calculated as the difference between BCVA and LLVA.
Initially, letters were to be read at a distance of 4 metres from the chart. If \<20 le
Week 12
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-0.6
± 7.59
GT005 High Dose [2E11 vg]
-1.1
± 9.63
Untreated Control
1.2
± 9.51
Week 24 (n=78,75,71)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-0.6
± 10.10
GT005 High Dose [2E11 vg]
-2.5
± 12.73
Untreated Control
0.5
± 12.01
Week 36 (n=75,72,71)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
0.0
± 9.90
GT005 High Dose [2E11 vg]
-2.6
± 13.40
Untreated Control
-0.1
± 11.12
Week 48 (n=73,73,69)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-0.5
± 10.31
GT005 High Dose [2E11 vg]
-1.5
± 15.18
Untreated Control
-0.4
± 12.93
Week 72 (n=63,67,58)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-0.5
± 13.15
GT005 High Dose [2E11 vg]
-5.2
± 17.24
Untreated Control
-2.5
± 14.93
Week 96 (n=54,49,35)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-3.1
± 16.11
GT005 High Dose [2E11 vg]
-2.2
± 13.48
Untreated Control
-5.9
± 16.82
Reading Performance, Measured as the MRS (Words Per Minute), as Assessed by Minnesota Low-vision Reading Test (MNRead) Chart: Summary Statistics for Change From Baseline by Visit for the Study EyeSecondary· Baseline, Weeks 12, 24, 36, 48, 72 and 96
The maximum reading speed (MRS) represents the highest reading speed an individual can achieve when print size is not a limiting factor. Essentially, it measures how quickly a person can read text when the print is large enough to be easily readable.
A higher count represents better visual functioning.
Week 24 (n=73,72,65)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-15.756
± 32.7268
GT005 High Dose [2E11 vg]
-12.368
± 43.2054
Untreated Control
-15.769
± 40.5051
Week 36 (n=71,70,65)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-18.488
± 54.7913
GT005 High Dose [2E11 vg]
-15.673
± 31.7802
Untreated Control
-3.689
± 94.1057
Week 48 (n=69,67,62)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-20.734
± 36.4110
GT005 High Dose [2E11 vg]
-6.678
± 49.0844
Untreated Control
-17.297
± 56.8547
Week 72 (n=57,64,53)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-24.485
± 45.8525
GT005 High Dose [2E11 vg]
-20.798
± 39.6796
Untreated Control
-26.121
± 40.8016
Week 96 (n=48,47,29)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-24.678
± 44.7777
GT005 High Dose [2E11 vg]
-25.178
± 39.7216
Untreated Control
-19.242
± 45.0703
Change From Baseline at Weeks 24, 36, 48, 72 and 96 in Functional Reading Independence (FRI) IndexSecondary· Baseline, Weeks 24, 36, 48, 72 and 96
The FRI index is a patient-reported outcome measure developed specifically for use in GA patients. The FRI index evaluates the level of independence subjects have in performing everyday activities that require reading, such as writing a cheque or reading a prescription.
Scores derived from the index range from 1 (unable to do) to 4 (total independence).
A higher score represents better visual functioning.
Week 24 (n=77,75,67)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-0.4
± 5.20
GT005 High Dose [2E11 vg]
-1.4
± 4.74
Untreated Control
-0.1
± 3.98
Week 36 (n=74,72,66)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-0.8
± 4.64
GT005 High Dose [2E11 vg]
-1.1
± 4.31
Untreated Control
-0.1
± 4.67
Week 48 (n=70,73,65)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-0.3
± 4.76
GT005 High Dose [2E11 vg]
-1.4
± 4.87
Untreated Control
-0.2
± 4.50
Week 72 (n=63,69,58)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-0.8
± 4.93
GT005 High Dose [2E11 vg]
-1.3
± 5.19
Untreated Control
-1.5
± 5.37
Week 96 (n=54,51,32)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-1.4
± 5.57
GT005 High Dose [2E11 vg]
-1.4
± 4.41
Untreated Control
-1.1
± 5.11
Change From Baseline at Weeks 24, 36, 48, 72 and 96 in Patient Reported Outcomes (Visual Function Questionnaire-25) - Composite ScoreSecondary· Baseline, Weeks 24, 36, 48, 72 and 96
The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.
The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the
Week 24 (n=77,78,67)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-1.466
± 12.8742
GT005 High Dose [2E11 vg]
-2.289
± 12.3295
Untreated Control
-1.270
± 11.2063
Week 36 (n=74,73,66)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-1.955
± 11.5060
GT005 High Dose [2E11 vg]
-3.479
± 12.0848
Untreated Control
-2.273
± 12.2395
Week 48 (n=70,74,65)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-2.501
± 12.9563
GT005 High Dose [2E11 vg]
-3.113
± 11.9974
Untreated Control
-4.403
± 14.2465
Week 72 (n=63,69,54)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-4.232
± 14.6259
GT005 High Dose [2E11 vg]
-3.432
± 11.3840
Untreated Control
-6.583
± 15.5133
Week 96 (n=54,51,33)
Group
Value
95% CI
GT005 Medium Dose [5E10 vg]
-6.341
± 14.4187
GT005 High Dose [2E11 vg]
-7.718
± 10.9016
Untreated Control
-6.804
± 15.4812
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events are reported from randomization to the end of study, at Week 96, up to a maximum timeframe of approximately 96 weeks..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
GT005@Medium Dose@[5E10 vg]
Serious: 22/87 (25%)
Deaths: 4/87
GT005@High Dose@[2E11 vg]
Serious: 25/86 (29%)
Deaths: 1/86
Untreated Control
Serious: 10/82 (12%)
Deaths: 1/82
Overall
Serious: 57/255 (22%)
Deaths: 6/255
Serious adverse events (75 terms)
Reaction
System
GT005@Medium Dose@[5E10 vg]
GT005@High Dose@[2E11 vg]
Untreated Control
Overall
Atrial fibrillation
Cardiac disorders
—
—
—
—
Myocardial infarction
Cardiac disorders
—
—
—
—
Retinal detachment - Study eye
Eye disorders
—
—
—
—
Endophthalmitis - Study eye
Infections and infestations
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
Hip fracture
Injury, poisoning and procedural complications
—
—
—
—
Cerebrovascular accident
Nervous system disorders
—
—
—
—
Syncope
Nervous system disorders
—
—
—
—
Acute kidney injury
Renal and urinary disorders
—
—
—
—
Angina pectoris
Cardiac disorders
—
—
—
—
Cardiac failure congestive
Cardiac disorders
—
—
—
—
COVID-19
Infections and infestations
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
—
Urinary retention
Renal and urinary disorders
—
—
—
—
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Acute coronary syndrome
Cardiac disorders
—
—
—
—
Acute myocardial infarction
Cardiac disorders
—
—
—
—
Atrioventricular block complete
Cardiac disorders
—
—
—
—
Bradycardia
Cardiac disorders
—
—
—
—
Bundle branch block left
Cardiac disorders
—
—
—
—
Cardiac arrest
Cardiac disorders
—
—
—
—
Chronic left ventricular failure
Cardiac disorders
—
—
—
—
Coronary artery dissection
Cardiac disorders
—
—
—
—
Other adverse events (440 terms — click to expand)
The purpose of this clinical study was to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration (AMD).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05481827 — ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to
· Phase 2
· enrolling by invitation
NCT04437368 — EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
· Phase 2
· terminated
NCT03846193 — FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry
· Phase 1, PHASE2
· terminated
Other recruiting trials for Dry Age-related Macular Degeneration
Currently open trials in the same condition.
NCT06536062 — Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma.
· NA
· recruiting
NCT06229665 — Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITEIIIB)
· Phase 2, PHASE3
· active not recruiting
NCT05797896 — Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study
· active not recruiting
NCT05706896 — Atrophic Age-related Macular Degeneration Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Pla
· NA
· recruiting
NCT04627428 — Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular
· Phase 1, PHASE2
· recruiting
Other Gyroscope Therapeutics Limited trials
Trials by the same sponsor.
NCT05481827 — ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to
· Phase 2
· enrolling by invitation
NCT04437368 — EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005
· Phase 2
· terminated
NCT03894020 — GTSCOPE - To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)
· terminated
NCT03846193 — FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry
· Phase 1, PHASE2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gyroscope Therapeutics Limited
Last refreshed: 28 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04566445.