Evidence map›Paper›PMID 39730975›Full record

ArticleEye (London, England)2025

Enrolment characteristics in age-related macular degeneration clinical trials: a cross-sectional study.

Brendan K Tao, Jim S Xie, Victoria Leung, Milin Patel, Jeffrey Xu, Cody Lo, Peng Yan, Nawaaz Nathoo, Wai-Ching Lam, Eduardo V Navajas and 2 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Eye (London, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Brendan K TaoFaculty of Medicine, The University of British Columbia, 317-2194 Health Sciences Mall, Vancouver, BC, V6T 1Z3, Canada.ORCID http://orcid.org/0000-0001-7069-3162
Jim S XieDepartment of Ophthalmology and Vision Science, University of Toronto, Suite 400, 340 College Street, Toronto, ON, M5T 3A9, Canada.
Victoria LeungTemerty Faculty of Medicine, University of Toronto, 6 Queen's Park Crescent West, Toronto, ON, M5S 1A8, Canada.
Milin PatelFaculty of Medicine, University of Ottawa, 451 Smyth Road #2044, Ottawa, ON, K1H 8M5, Canada.
Jeffrey XuFaculty of Science, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.
Cody LoOttawa Hospital Eye Institute, University of Ottawa, 501 Smyth Road, Ottawa, ON, K1H 8M2, Canada.
Peng YanDepartment of Ophthalmology and Vision Science, University of Toronto, Suite 400, 340 College Street, Toronto, ON, M5T 3A9, Canada.
Nawaaz NathooDepartment of Ophthalmology and Visual Science, The University of British Columbia, 2550 Willow St., Vancouver, BC, V5Z 3N9, Canada.
Wai-Ching LamDepartment of Ophthalmology and Visual Science, The University of British Columbia, 2550 Willow St., Vancouver, BC, V5Z 3N9, Canada.
Eduardo V NavajasDepartment of Ophthalmology and Visual Science, The University of British Columbia, 2550 Willow St., Vancouver, BC, V5Z 3N9, Canada.
Rajeev MuniDepartment of Ophthalmology and Vision Science, University of Toronto, Suite 400, 340 College Street, Toronto, ON, M5T 3A9, Canada.
Radha P KohlyDepartment of Ophthalmology and Vision Science, University of Toronto, Suite 400, 340 College Street, Toronto, ON, M5T 3A9, Canada. radha.kohly@utoronto.ca.ORCID http://orcid.org/0000-0002-1355-6599

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesTo investigate demographic enrolment characteristics in age-related macular degeneration (AMD) trials. SUBJECTS/

methodsClinicaltrials.gov was searched with "age-related macular degeneration" to identify RCTs with double, triple, or quadruple masking. Trial (e.g., study location, phase, masking, trial initiation year, and sponsor origin) and patient demographic data were collected. Sex-based AMD disease burdens were retrieved from the Global Burden of Disease database to calculate pooled female population-to-prevalence ratios (PPRs). Equitable trial enrolment was defined as PPR between 0.8-1.2. Demographic proportions were evaluated across trial characteristics using the Kruskal-Wallis test (alpha = 0.05) followed by post hoc comparisons. Secondary outcomes included absolute number of enrolled female, racial, and ethnic groups, and the association of trial characteristics with these demographics.

resultsWe included 106 trials (77,939 patients; 46.3% female), spanning 1990-2020. The pooled female PRR was 0.88 (95% confidence interval [CI]: 0.82, 0.94). PPR values were inconclusive studies with quadruple blinding; phase I, III, IV, or not applicable status; foreign (non-US) site; US-only and foreign-only sponsor; and an initiation year before 2010. There was no significant difference in PPR between sublevels of analysed trial characteristics. Of the 74 (69.8%) trials that adequately detailed race, White participants comprised the largest group (N = 57,917; 82% of total participants). Thirty-seven (34.9%) trials adequately detailed ethnicity. The absolute enrolment of race and ethnic groups did not generally exhibit significant difference between sublevels of analysed trial characteristics.

conclusionsFemale enrolment was commensurate to their disease burden across all trial characteristics. Race and ethnicity were under-reported. Future trials should prioritise equitable study enrolment strategies.

Indexed as

Clinical Trials as TopicMacular DegenerationPatient SelectionAgedCross-Sectional StudiesFemaleHumansMaleMiddle AgedRandomized Controlled Trials as Topic

Identifiers

PMID39730975
PMCPMC11978819

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.