Trial · NCT04663750
Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
NCT04663750, Phase 3, Recruiting, King's College Hospital NHS Trust
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER). Trials, record NCT04663750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04663750
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
- NCT number
- NCT04663750
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 210 participants, estimated
- Lead sponsor
- King's College Hospital NHS Trust
- Conditions
- Eye Diseases, Macular Degeneration, Wet, Sub-Macular Hemorrhage
- Interventions
Pars plana vitrectomy, Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until month 12, subretinal injection of recombinant TPA (Alteplase) up to a maximum of 25 micrograms in 0.2 mls, Intravitreal 20% sulfahexafluoride (SF6) gas tamponade
- First posted
- 2020-12-11
- Last updated
- 2026-09-11
- Other registries' IDs
- eudract:2020-004917-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | assessment of Early Treat of Diabetic Retinopathy Study (ETDRS) letters of best-corrected visual acuity (BCVA) in the study eye. | 12 months | The primary outcome is the proportion of participants with a BCVA gain ≥10 ETDRS letters in the study eye at the 12 month visit. |
| Secondary | Assessment of Early Treatment Diabetic Retinopathy Study (ETDRS) letter improvement in Best-Corrected Visual Acuity (BCVA) in the study eye | 6 months | Change in ETDRS letters in BCVA in the study eye at the month 6 visit. |
| Secondary | Mean ETDRS BCVA | 6 and 12 months | |
| Secondary | Radner maximum reading speed | 6 and 12 months | |
| Secondary | Area of scotoma size using Humphrey Field Analyser 10-2 or equivalent | 6 and 12 month | |
| Secondary | National Eye Institute 25-item visual function questionnaire (NEI VFQ-25). composite score. | 6 and 12 months. | |
| Secondary | EQ-5D-5L with vision bolt-on score. | 6 and 12 months. | |
| Secondary | Presence/absence of subfoveal fibrosis and/or atrophy and area of fibrosis/atrophy using multimodal reading centre image analysis. | 12 months. | Presence or absence of subfoveal fibrosis and/or atrophy and area of fovea-involving fibrosis/atrophy assessed using multimodal imaging by an independent reading centre, combining spectral domain optical coherence tomography (SD-OCT), fundus autofluorescence (FAF) and stereo fundus photographs. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04663750
GET https://conductscience.org/api/trials/v1/NCT04663750/registered